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:Â Â Â Lead QA
Req ID:Â 2504
Job Description:
Planning and scheduling of QA activities.
- Review and approval of General Quality system documents (SOPs, Site master file, Validation master plan, quality agreements and quality policies)
- Review and approval of Manufacturing documents (batch records, SOPs, EOPs, IOPs, Specifications, analytical methods, technology transfer documents) pertaining to Biologics function.
- Review of Quality matrix for periodic management review meetings.
Participation and approval of facility, process equipment and EHS risk assessment. - Assessment and approval of change controls, OOS, deviations, incidents, risk assessments, customer complaints & CAPA.
- Release of GMP batches for dispatch.
- Handling of client / regulatory audits and preparation of response for compliance.
- Internal audits and GMP rounds.
- Review and approval of qualification and validation documents for compliance against GMP standards and current industry practices.
- Training of employees on Quality Management System procedures, data integrity and Good Documentation Practices.
- Development of team skills within Formulations QA team.
