19 Aug
|
RK Life care
|
Haryana
19 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