Senior QA Manager (India)

Senior QA Manager (India)

16 Aug
|
Rk Life Care
|
India

16 Aug

Rk Life Care

India

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 strong 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.
- 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 manufacturing plant.
- Proven experience in facing international regulatory audits and customer audits.
- Strong practical knowledge of cGMP, QMS, SOPs, CAPA, Change Control, Deviation, OOS/OOT, Risk Management, and Data Integrity.
- Experience in handling audit observations and preparing effective CAPA and compliance responses.
- Good understanding of pharmaceutical manufacturing processes and documentation systems.
- Strong leadership, communication, analytical, and decision-making skills.

Preferred Candidate Profile

Preference will be given to candidates who have independently handled QA operations in a Dry Injection facility, have successfully faced international audits, and can demonstrate robust experience in maintaining GMP compliance and managing site-wide quality systems.

Candidates should apply with an updated resume clearly mentioning their Dry Injection experience, total QA experience, and international audit exposure.

Pay: ₹25,000.00 - ₹50,000.00 per month

Work Location: In person

📌 Senior QA Manager (India)
🏢 Rk Life Care
📍 India

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