15 Aug
|
RK Life care
|
Haryana
15 Aug
RK Life care
Haryana
Job Description
Company: RK Life Care Inc
Location: Jajjar, Haryana
Department: Quality Assurance (QA)
Job Type: Full-time
Job Summary
We are looking for an experienced QA Manager to oversee Quality Assurance activities at a pharmaceutical manufacturing facility in Jajjar, Haryana. The ideal candidate must have minimum 5 years of relevant pharmaceutical QA experience, with solid hands-on exposure to a Dry Injection / Dry Powder Injection manufacturing facility and experience in facing international regulatory and customer audits.
The candidate should be capable of independently managing QA systems, ensuring GMP compliance, handling investigations and CAPA, and leading the site through audits and inspections.
Key Responsibilities
- Manage and oversee day-to-day Quality Assurance activities for the manufacturing facility.
- Ensure strict compliance with cGMP, SOPs, quality systems, and applicable regulatory requirements.
- Provide QA oversight for Dry Injection / Dry Powder Injection manufacturing and filling operations.
- Review and approve Batch Manufacturing Records,
Batch Packing Records, SOPs, protocols, reports, specifications, and other GMP documentation.
- Handle and lead investigations related to deviations, OOS/OOT, incidents, complaints, and CAPA.
- Manage Change Control, Risk Assessment, CAPA, self-inspection, and quality improvement systems.
- Ensure effective implementation of QMS and data integrity practices across manufacturing and support functions.
- Lead preparation for and actively participate in international regulatory audits and customer audits.
- Independently coordinate audit responses, observations, CAPA commitments, and follow-up actions.
- Ensure continuous GMP compliance across Production, Warehouse, Engineering, QC, and other departments.
- Conduct internal audits, self-inspections, and GMP compliance assessments.
- Review validation, qualification, cleaning validation, process validation, and related quality documentation.
- Monito
📌 Senior QA Manager (Haryana)
🏢 RK Life care
📍 Haryana