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Current Openings - API Plant

Peptide Synthesis (reactions)


Position Title : Incharge

No. Of Positions : 1

Job Description

M.Sc. chemistry/ with 5-8 years experience in peptide synthesis



Position Title : Chemist

No. Of Positions : 4

Job Description

M.Sc. chemistry/ with 5-8 years experience in peptide synthesis


Purification and lyophilization


Position Title : Incharge

No. Of Positions : 1

Job Description

M.Sc. chemistry/ Bioetch with 5-8 years experience in peptide / protein purification and handling of Preparative columns and HPLC.



Position Title : Chemist

No. Of Positions : 4

Job Description

M.Sc. chemistry/ Bioetch with 1-5 years experience in peptide / protein purification and handling of Preparative columns and HPLC.


QC analytical


Position Title : Chemist

No. Of Positions : 2

Job Description

HPLC / UPLC handling, documentation etc.


Maintenance


Position Title : Executive

Education Qualification : B. Tech /M. Tech

Job Description

  • Responsible for monitoring Instruments calibration activity and maintain the records
  • Responsible for preparation of instruments calibration schedule and calibration activities in SAP
  • Responsible for preparation and review of all related Electrical maintenance records, ensure that are completed and signed
  • Responsible for monitoring of preventive and General Maintenance activities and maintain records
  • Responsible to receive and issue of Engineering and consumable material through SAP
  • Responsible for preparation of new SOPs and revision of existing SOPs in Electrical Maintenance Department
  • Responsible to initiation of change controls to change the existing procedure and systems related to maintenance department
  • Responsible to perform and monitoring of SAP plant maintenance module related activities
  • Responsible to perform of SAP plant maintenance module related activities
  • Responsible for follow up of deviations and investigations
  • Responsible to follow up the safety during Electrical maintenance work
  • Responsible to ensure that the employees working in electrical maintenance department are aware of all procedures and systems in the company
  • Responsible to follow the standing order of the company as well change in company policies are to be adopted regularly
  • Responsible to monitor the welfare of the staff working in the department
  • Responsible to perform and Co-ordinate training programs, related to maintenance department staff and employees as per schedule
  • Responsible for any other activities assigned by HOD


Position Title : Assistant - Manager

Education Qualification : B. Tech / M. Tech

Job Description

  • Responsible for perform the Devices /instruments used in the plant are calibrated as per calibration schedule plan and to review the relevant records.
  • Responsible to follow up the prepare and review of all related maintenance records ensure that are completed and signed.
  • Responsible to perform preventive maintenance activities and maintain records.
  • Responsible to perform the cleaning of water pipe lines, storage tanks, DM plant and AHU filters.
  • Responsible to perform training programs related to maintenance department staff and employees as per schedules.
  • Responsible to follow up the safety during maintenance work.
  • Responsible to ensure that the employees working in maintenance department are aware of all procedures and systems in the company.
  • Responsible to follow the standing orders of the company as well change in company policies are to be adopted regularly.
  • Responsible to monitor the welfare of the staff working in your department.
  • Responsible for any other activity Assigned by HOD.

Quality Control


Position Title : Executive

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible to perform the analysis of finished product samples.
  • Responsible to perform the analysis of finished non oncology products related to GC analysis.
  • Responsible for the preparation of mobile phase related to HPLC analysis.
  • Responsible for the safe handling of laboratory chemicals.
  • Responsible for reporting of incidents, deviations and out of specification results.
  • Responsible for maintaining equipment usage log books.
  • Responsible for maintaining the documents as per GLP and cGMP.
  • Responsible for any other activity assigned by Head-Quality Control.


Position Title : Sr Executive

Education Qualification : B.Sc / M. Sc 

Job Description

  • Responsible to perform the data review of Raw materials /finished products /stability samples.
  • Responsible to perform the data review of in process / intermediate samples.
  • Responsible for reviewing the working standards /calibrations.
  • Responsible to report deviations/incidents/OOS and their investigation.
  • Responsible for reporting of incidents, deviations and out of specification results.
  • Responsible for reviewing of electronic raw data.
  • Responsible for reviewing the usage log books
  • Responsible for maintaining the documents as per cGMP
  • Responsible for any other activity assigned by Head-Quality Control and Head-Quality.


Position Title : Chemist / Sr.Chemist

Education Qualification : B. Sc / M. Sc 

Job Description

  • Responsible to perform the analysis of stability samples as per schedule.
  • Responsible for the safe handling of laboratory chemicals, reagents.
  • Responsible for reporting of incidents, deviations add out of specification results.
  • Responsible for maintaining equipment usage log books.
  • Responsible for maintaining the documents as per GLP and cGMP
  • Responsible for any other activity assigned by Head-Quality Control.
  • Responsible for monitoring of stability chambers temperature and humidity.


Position Title : Dy - Manager

Education Qualification : B. Sc / M. Sc

Job Description

  • Standard operating procedures (SOP’s).
  • Specifications and test procedures, Stability study protocols and reports.
  • Validation protocols and reports, Qualification documents.
  • All the documents related to quality.
  • Responsible for review of certificate of analysis of final API’s.
  • Responsible for stability Activities.
  • Responsible for ensuring the calibrations of all the instruments.
  • Timely testing and release of raw materials, packing materials, in process, intermediates and API’s.
  • Responsible for internal quality audits as per cGMP and ensure corrective action taken on those non conformance.
  • Responsible for training need identification of all employees in quality control.
  • Responsible for investigation and ensure corrective and preventive actions for critical deviations.
  • Responsible for training need identification of all employees in quality control.
  • Responsible for investigation and ensure corrective and preventive actions for critical deviations non-conformance, out of specification and out of trend reports, incidences, customer quality complaints.
  • Responsible for implementation of change controls related quality control.
  • Implementation and ensuring the Quality management system in Quality control department.
  • Responsible for investigation related to quality on return goods and compliant samples.
  • Responsible for any other activity assigned by Head of Site Quality.

Quality Assurance


Position Title : Executive

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible For releasing of finished product to the markets, verifying of all dispatch related documents in coordination with QA/QC, marketing department, production and warehouse.
  • Product reconciliation and their documentation of finished product.
  • Responsible for updating and maintaining of finished products distribution registers, Label inventory control registers, Documentation distribution records, seal and tags control registers and other related documents involved in dispatch planning.
  • Responsible for review of new SOPs and revision SOPs in Quality Assurance Department.
  • Responsible for the review of Batch Production Records for each API and intermediates.
  • Responsible for the retrieval of completed / executed BPR’s and for updating the concerned registers from time to time for each API and intermediates.
  • Responsible for Preparation and review of APR’s.
  • Responsible for handling of changes to the existing systems, documents, procedure, processes, Specifications and test methods of Raw materials, Intermediates and Finished products.
  • Responsible for Archiving BPRs Year / Product / Stage-wise in Batch Number Sequence.
  • Responsible for follow up of batch deviations investigations.
  • Responsible for any other activity assigned by Department Head.


Position Title : Assistant-Manager

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible for review of new SOPs and revision SOPs in Quality Assurance Department.
  • Responsible for the review of Batch Production Records, Analytical reports for each API and intermediates.
  • Responsible for Audit compliances.
  • Responsible for preparation and Review of the Validation Master Plan.
  • Responsible for preparation and Review of the Site Master Plan.
  • Responsible for handling of returned goods.
  • Responsible for handling and investigation of deviations.
  • Responsible for review and approval of technology transfer documents and analytical method transfer documents.
  • Responsible for review of Validation Protocols and Reports, Equivalence reports (Process, Analytical & Cleaning)
  • Responsible for review of APQR.
  • Responsible for follow up of batch deviations and investigations.
  • Responsible for the retrieval of completed / executed BPR’s and for updating the concerned registers time to time for each API and intermediates.
  • Responsible for monitoring the validations of the Purified Water System and AHU’s, N2 compressed air environmental monitoring reports and trends.
  • Responsible for compilation of data for qualification of vendors and conducting vendor audits.
  • Responsible for reviewing the executed
  • BPRs and to make necessary comments.
  • Responsible for Achieving BPRs Year/Product/Stage-wise in Batch Number Sequence.
  • Responsible for investigation of customer complaints and records.
  • Responsible for coordinating the internal quality Audits.
  • Responsible for review of qualification documents of critical equipments used in the manufacturing process of APIs.
  • Responsible to involve in the training activities.
  • Responsible for handling of changes to the existing systems,documents,processes,specifications and test methods of Raw materials, Intermediates and Finished Products.
  • Responsible for Management review meeting.
  • Responsible to release the Finished Product to market.
  • Responsible for coordinating & monitoring the external calibrations, preventive maintenance & temperature mappings.
  • Responsible for the activities shall be assigned to not below the rank of Executive in his absence.
  • Responsible for involving in the Quality Risk management activities.
  • Responsible for review and approve for handling of OOS/OOT/CAPA.
  • Responsible for giving line clearance during product change over.
  • Responsible for any other activity assigned by Head / In-charge - QA


Position Title : Chemist / Sr.Chemist

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible for the review of Batch Production Records for each API and intermediates.
  • Responsible for the retrieval of completed / executed BPR’s and for updating the concerned registers from time to time for each API and intermediates.
  • Responsible for reviewing the executed BPR’s and BCR’s to make necessary comments.
  • Responsible for Preparation and review of APR’s.
  • Responsible for data review for product quality reviews for every API.
  • Responsible for Archiving BPRs Year / Product / Stage-wise in Batch Number Sequence.
  • Responsible for follow up of batch deviations investigations.
  • Responsible for any other activity assigned by Department Head.

Production


Position Title : Chemist / Sr.Chemist

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible for execute the Batch production records, while performing the production activities.
  • Responsible for Producing Intermediates, APIs as per approved BPRs.
  • Responsible for performing all production batch records as per approved BPR and ensure that completeness of the document.
  • Responsible to ensure that all production deviations are reported in the BPR and inform to Shift Incharge for evaluation.
  • Responsible to ensure that production facilities are clean and when appropriate disinfected.
  • Responsible to ensure that the premises and equipment are maintained in good condition and activities are documented.
  • Responsible to monitor temperature & pressure differentials in manufacturing area.
  • Responsible for implementation of corrective & preventive actions on production processes and products.
  • Responsible to use all safety equipment’s while performing production activities as per needs & follow up safety rules & implement the same.
  • Responsible to report all the activities of the department to the Shift Incharge/Executives.
  • Responsible for any other activity assigned by the Shift in-charge / Executive.


Position Title : Executive

Education Qualification : B. Sc / M. Sc

Job Description

  • Responsible for reviewing all production batch records and cleaning records, ensuring that these are completed and signed.
  • Responsible to ensure that all production deviations are reported and evaluated and critical deviations are investigated and the conclusions are recorded.
  • Responsible for carry out batch operations as per approved manufacturing instructions and SOPs
  • Responsible to monitor critical process parameters according to BPRs.
  • Responsible to ensure that production facilities are clean and when appropriate disinfected.
  • Responsible to follow up of sifting, blending and packing activities of various products.
  • Responsible for evaluating proposed changes in Product, process or equipment and implementation as appropriate.
  • Responsible for providing safety equipments as per needs & follow up safety rules & implement the same
  • Responsible to ensure that the employees working and aware of all standard operating procedures and systems in the company.
  • Responsible for storage, usage and re-conciliation of materials.
  • Responsible to cross check the calibration of production equipments.
  • Responsible to report all the related matters of the department to HOD.
  • Responsible for any other activity assigned by HOD.

Quality Control

Position Title : Sr Chemist / Executive– Quality Control- GCMS

Education Qualification : M.Sc (Chemistry)

Experience : 3 - 6 Years experience.

Job Description

  • Candidate should have experience in handling the GCMS
  • Performing routine analysis along with having knowledge of method development and validation, conducting internal audits and preparing trend reports.
  • Responsible for staff development through proper induction and training.
  • Analytical experience in the API Pharma industry.
  • Should be well versed with QC activities of API.
  • Exposure to regulatory audits


Quality Control

Position Title : Microbiologist / Sr Microbiologist

Education Qualification : M.Sc (Microbiologist)

Experience : 2 - 5 Years experience.

Job Description

  • Microbial limit test analysis for raw material, finished products, stability samples and packing material.
  • Responsible for Bacterial endotoxin test for raw material and finished products.
  • Experience in Identification of Standard organisms and in-house isolates  up to species level using BBL or other suitable instruments
  • Disinfectant Efficacy study
  • Investigation and reporting of Out of Specification, out of alert , out of action , Out of trend ,Deviation or Incidence observed during the activity.
  • Responsible for operation of Incubators, cooling cabinets, plasma freezer and Duo Block Incubator, Laminar air flow, Bio-safety cabinet, Garment storage cabinets, ceiling suspended laminar air flow, water bath, dynamic pass boxes, colony counter and static pass boxes.
  • Operation of Horizontal autoclave, vertical autoclave, Depyro oven, Hot air oven and Heat Seal machine.
  • Preparing and updating of all sops, specification, test methods validation protocols, study protocols and reports.
  • Environmental monitoring, media preparation activity.


Quality Assurance

Position Title : Executive / Sr Executive

Education Qualification :  B.Sc/M.Sc (Chemistry)

Experience : 5 - 8 Years experience.

Job Description

  • Review process documents stage-wise and facilitate timely release of batches.
  • Perform IPQA checks during production.
  • Review and compile deviations and change controls.  Ensure quality compliance of the product through internal audits.
  • Knowledge of SOP's and IPQA processes and exposure to external audits.
  • Experienced candidates from Pharmaceutical / Chemical Industry preferred.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired


Production

Position Title :  Chemist / Sr. Chemist

Education Qualification : B. Sc / M. Sc

Experience : 2 - 4 Years experience.

Job Description

  • Job Description: Supervise batch charging and verification of RM Quantities and maintain Batch Production records
  • Check equipment’s and connected accessories for cleanliness and operate them as per the process norms.
  • Monitor and maintain all parameters as per SOPs and ensure strict compliance with GMP and safety norms.
  • Seek assistance for or escalate all process deviations/maintenance jobs. Experienced candidates from API Pharmaceutical / Chemical Industry only may apply.
  • Knowledge of SOP's and manufacturing processes will be an added advantage.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired.


ADL

Position Title :  Chemist / Sr Chemist / Executive

Education Qualification : M. Sc / M Pharm (Chemistry)

Experience : 3 - 6 Years experience.

Job Description

  • Candidate should have good knowledge of Analytical Chemistry
  • Candidate should have experience in handling either of HPLC/ GC/ LCMS/ GCMS/ ION Chromatography, XRD and Particle size analysis
  • Performing routine analysis alongwith having knowledge of method development and validation,
  • Good experience in handling of standard and qualification
  • Responsible for staff development through proper induction and training.
  • Analytical experience in the API /Pharma industry will be preferred.
  • Exposure to regulatory audits and eagerness to work on the shop floor is desired


CR & D

Position Title :  Chemist/ Sr Chemist

Education Qualification : M.Sc /M Pharm(Chemistry)

Experience : 3 - 4 Years experience.

Job Description

Desire Knowledge

Exposure to API process Research, skill to interpret data from analysis, should have understanding of polymorphism, ability to successfully scale up batches for DMF filling and knowledge of advanced organic chemistry/follow the GLP and the proper documentation/E-LNB system.


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*Candidate can apply once for single location

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