Quality Control Officer

Zydus Lifesciences; Solan; On-site; INR 300,000 - 540,000; Full time

Job summary

Zydus Lifesciences in India seeks a meticulous Quality Control laboratory professional to ensure training, testing documentation, instrument maintenance, and compliance with GDP and SOPs. You will manage standards, calibrations, data entry in LIMS, inventory, and incident investigations in a fast-paced QC setting.

The role requires strict adherence to procedures, proper PPE usage, and timely reporting of any laboratory incidences, with daily temperature monitoring and interaction with service

Responsibilities

• Ensure training is completed for each activity/instrument prior to use; align with respective TNI.
• Document all lab tests contemporaneously in authorized worksheets or bound books.
• Record sample inward entries in SAP/LIMS and assign analytical reference numbers; store samples under recommended conditions until analysis is complete.
• Operate and maintain laboratory equipment/instruments as per the analyst qualification program.
• Record entries in log books whenever instruments are used in analysis.
• Perform all related activities (bench reagents, indicators, volumetric solution preparation, factor determination, etc.) following approved procedures.
• Prepare and qualify working standards against reference/certified/primary standards; store standards per specified conditions and review against catalogue; procurement where needed.
• Check availability of analytical resources (chemicals/reagents/standards) before starting analysis.
• Take online prints and perform data punching in the LIMS.
• Monitor laboratory temperature daily.
• Send samples to a public testing laboratory for analyses not possible in-house.
• Maintain controlled laboratory practices in the quality control department.
• Document raw data as per current GDP.
• Follow SOPs of the quality control department and related areas.
• Follow specifications, STP, GTP, and protocol during analysis.
• Use applicable PPEs during testing in the laboratory.
• Stay updated with regulatory requirements and train subordinates and colleagues accordingly.
• Keep workspace clean and tidy and participate in routine troubleshooting as needed.
• Ensure upkeep of instruments/equipment.
• Ensure laboratory inventory management.
• Inform section head immediately of any laboratory incidences (OOS/OOT/OOC) and day-to-day activities.
• Investigate laboratory incidences (OOS/OOT/OOC) in consultation with department/section head.
• Manage all standards for issuance and usage.
• Perform calibration of instruments as per the planner or as required.
• Manage all calibrators and their documents.
• Perform instrument qualification as per requirements.
• Coordinate with in-house and external service engineers as required.
• Raise change controls applicable to quality control laboratory and testing.
• Prepare standard operating procedures for the quality control department.

Job description

• 1. To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI.
• 2. To ensure that all tests carried out in the laboratory are documented contemporaneously in an appropriate authorized and controlled worksheet/ bound book.
• 3. To make entries in the sample inward register / SAP / LIMS as required for assigning analytical reference number and to store at recommended storage condition until completion of the analysis.
• 4. To operate and maintain laboratory equipment/instrument as per analyst qualification program.
• 5. To ensure that entries in log books are made where ever instruments are used in the analysis.
• 6. To perform all associated activities (bench reagents, indicators, volumetric solution preparation, factor determination etc.) required for sample testing by following the approved procedures.
• 7. To prepare and qualify working standards against reference standard /certified standard/ primary standards. To ensure all primary standards/working standards/certified standards/reference standards are stored as per the storage conditions specified and documented. To review Pharmacopoeial reference standards against their catalogue & its procurement.
• 8. To check the availability of analytical resources like chemicals/reagents / standards etc. before start of the analysis.
• 9. To take online print and perform data punching in the LIMS.
• 10. To monitor temperature of laboratory daily.
• 11. To send those samples to public testing laboratory for analysis for tests not able to be carried out in laboratory.
• 12. To maintain and ensure controlled laboratory practice in the quality control department.
• 13. To document the raw data as per current GDP.
• 14. To follow the SOPs of Quality control department and related area.
• 15. To follow Specification, STP, GTP and protocol during analysis.
• 16. To use applicable PPEs (personal protective equipment) while performing testing in the laboratory.
• 17. To keep himself / herself updated with current regulatory requirements and train the subordinates and colleagues for day to day activities as well as regulatory.
• 18. To keep the things and his work area clean and tidy and get involved for the routine trouble shooting (if any).
• 19. To ensure up-keeping of the instrument/equipment.
• 20. To ensure laboratory inventory management.
• 21. To inform section head any laboratory incidence/ OOS/ OOT/ OOC on its immediate occurrence and for day to day activities.
• 22. To investigate laboratory incidence/ OOS/ OOT/ OOC (if any) under consultation with the department head/section head.
• 23. To manage all standards for issuance and its usage.
• 24. To perform the calibration of instruments as per the planner and / or as and when required.
• 25. To manage all calibrators used for calibration and their documents.
• 26. To perform the qualification of instruments as per the requirements.
• 27. To co-ordinate with in-house service engineers and / or external service engineers as and when required.
• 28. To raise change controls applicable to quality control laboratory and testing.
• 29. To prepare the standard operating procedure for quality control department.