Key Responsibilities
- Lead and manage the Quality Assurance (QA) function for pharma /chemical ( Additives)manufacturing operations.
- Ensure compliance with cGMP, WHO-GMP, ISO 9001, ISO 14001, and other applicable regulatory standards.
- Handle and coordinate customer audits, supplier audits, internal audits, and regulatory inspections.
- Prepare, review, and maintain SOPs, quality manuals, validation documents, CAPA, change controls, deviations, and risk assessments.
- Monitor implementation of Corrective and Preventive Actions (CAPA) and ensure timely closure.
- Support qualification and validation activities related to equipment, processes, and cleaning.
- Review batch records, quality reports, and ensure product release as per approved specifications.
- Drive continuous improvement initiatives to enhance quality systems and operational efficiency.
- Train employees on GMP, quality systems, and regulatory requirements.
- Coordinate with Production, QC, Regulatory, and Supply Chain teams to ensure compliance and product quality.
Audit Experience Required
The candidate should have hands-on experience in handling:
- Customer Audits
- ISO 9001 Audits
- WHO-GMP Audits
- Internal Quality Audits
- Supplier/Vendor Audits
- Regulatory Inspections
Desired Skills
- Strong knowledge of GMP & Quality Systems
- Excellent audit handling and documentation skills
- Leadership and team management capability
- Analytical and problem-solving skills
- Effective communication and stakeholder management
Preferred Candidate Profile
- Experience in Pharma Chemical / API / Specialty Chemical manufacturing industry.
- Proven track record of successfully handling multiple external and regulatory audits.
- Ability to establish and strengthen robust Quality Management Systems .
Pay: ₹30,000.00 - ₹40,000.00 per month
Benefits:
- Leave encashment
- Provident Fund
Ability to commute/relocate:
- Khanna, Ludhiana, Punjab: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):
- What is your current Salary and Notice Period ?
Experience:
- Quality assurance: 6 years (Preferred)
- Quality audits: 5 years (Preferred)
Work Location: In person
