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:
- 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
