AQA-Reviewer Position Vacant @ Syngene | Apply Online

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Syngene

Incorporated in 1993. Syngene is India’s largest contract research organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services.

Our highly experienced scientific and project management teams ensure:

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  • Timely execution of projects
  • Cost effectiveness and quality of the projects
  • Confidentiality and protection of intellectual property

Job Title  AQA-Reviewer

Req Id : 2370

Job Description:

  • Handling of customer projects and to ensure the documents related to Quality Control are reviewed and approved.
  • Review and approval of the Analytical testing records and Final Batch release in SAP.
  • Dispatch approval for all products and issuing the COA as per the requirement.
  • Review of Analytical Method validation, Analytical method transfer, Excel validations, Forced degradations – protocols and reports,
  • Review and approval of stability summary and stability reports generated by QC.
  • Handling and being part of the investigations related to deviations, Laboratory incidents, Out of calibrations, Out of specifications, CAPA and Out of trend.
  • Issuance of Documents (Annexures, ODS, Calibration sheets, Log sheets etc)
  • Handling & management of deviations, Laboratory incidents coordinating in identifying the root cause investigations with CAPA identification, approval and the final approval of deviation.
  • Handling and evaluation of change control, verification and implementation of the Corrective and preventive action.
  • Review & approval of specifications for RM/IP/FP of QC Biologicals.
  • Review and approval of working/Lab/impurity/GC standards/ thawing time of standards COA and reports.
  • Verification of Instrument operating procedures, IQ/OQ/PQ/DQ of all instruments of QC.
  • Conducting regular GMP rounds in the Quality control laboratory.
  • Coordinating with the laboratory personnel in handling of the customer queries
See Also  MSc Chemistry Project Assistant Post Vacant @ NCL, Pune

Apply Online 

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