Senior Quality Assurance Lead
3 days ago
About the Role:
We are seeking a highly experienced and skilled Senior Quality Assurance Lead to join our team at Aurigene Pharmaceutical Services Limited. The successful candidate will be responsible for implementing, monitoring, and continuously improving quality systems, corporate guidelines, and new initiatives within our organization.
Key Responsibilities:
- Review and approve Standard Operating Procedures, Guidelines, Policies, and Change Control Documents.
- Maintain laboratory compliance and ensure inspection readiness at all times.
- Investigate incidents in a timely manner and implement Corrective Action Preventive Action (CAPA) for all projects and general incidents.
- Negotiate, approve, and monitor customer quality agreements to ensure compliance.
- Qualify new business partners by following established procedures and audit/approve quality agreements.
- Engage with customers, respond to queries, and facilitate quality team success in technology transfer and regulatory affairs.
- Verify gate clearance documents, support DQA members, and perform internal and unannounced audits.
- Present quality issues, provide training on cGMP, GDP, GLP, SOPs, and quality guidelines, and review/calibration schedules.
About You:
- M.Sc./M.Pharm/Chemical Engineer/Ph.D. with 14-17 years of experience.
- Preferably, experience in Analytical Development, Development Quality Assurance, or API Quality Assurance.
What We Offer:
- A dynamic work environment with opportunities for growth and development.
- A competitive salary package and benefits.
- The chance to work with a talented team of professionals.
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