18 Aug
|
Rk Life Care
|
Haryana
18 Aug
Rk Life Care
Haryana
Company: RK Life Care Inc
Location: Jajjar, Haryana
Department: Quality Assurance (QA)
Job Type: Full time
Job Summary
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.
- Monitor environmental, aseptic/GMP controls and contamination-control practices relevant to Dry Injection operations.
- Train and guide QA personnel on GMP, documentation, QMS, and regulatory expectations.
- Work closely with senior management and cross-functional teams to resolve quality and compliance issues.
Required Qualifications & Experience
- Bachelor's/Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.
- Minimum 5 years of relevant experience in Pharmaceutical Quality Assurance.:
- Mandatory experience in a Dry Injection / Dry Powder Injection m
📌 QA Manager (Haryana)
🏢 Rk Life Care
📍 Haryana