Head of Quality Assurance

To lead and manage the Quality Assurance function of the organization and ensure compliance with ISO 9001:2015, GMP guidelines, regulatory requirements, and company standards for the manufacturing of chemical/pharmaceutical intermediates.

Key Responsibilities:

1. Quality Systems & Documentation

• Review and approve ISO 9001:2015-related documents.
• Review and approve Quality Management System (QMS) documents, procedures, and policies.
• Review and approve validation and qualification documents.
• Review and approve analytical/stability data, protocols, and laboratory control records.
• Approve specifications, MOA, master batch production records, and method transfer documents.
• Ensure batch production and laboratory control records are reviewed before release.

2. Batch Release & Control

• Release or reject finished products as per quality standards.
• Approvals for reprocessing/reworking of finished products.
• Ensure stability study and hold-time study are conducted wherever required.
• Ensure out-of-specification (OOS) test results are investigated per procedure.

3. Audits & Compliance

• Ensure internal audits are performed as per schedule.
• Prepare Audit Compliance Reports for customer audits and ISO 9001:2015 audits.
• Conduct IPQA rounds across departments to ensure compliance to standards.

4. Investigations, CAPA & Change Control

• Ensure critical deviations are investigated and appropriate CAPA actions are taken.
• Review and approve changes impacting intermediate or finished product quality.
• Investigate quality-related complaints and ensure resolution as per procedures.

5. Vendor & Material Quality

• Review and approve RM vendor qualification/related documents.

6. Training & Development

• Ensure GMP and quality training is conducted as per schedule.
• Motivate and guide team members for continual improvement in Quality, EHS, and GMP compliance.

7. EHS & Safety Responsibilities

• Implement and follow Quality & EHS policies in day-to-day work activities.
• Identify and rectify unsafe acts and unsafe working conditions.
• Ensure compliance with PPE usage and workplace safety standards.
• Identify potential fire-prone areas and inform EHS promptly.

Qualifications & Experience:

• Bachelor’s/Master’s in Chemistry, Pharmacy, or related discipline.
• Minimum 12-15 years of experience in Quality Assurance in a Chemical/Pharma Intermediate manufacturing environment.
• Strong knowledge of ISO 9001:2015, GMP, regulatory guidelines, and documentation practices.

Key Skills

• Excellent knowledge of IPQA, QMS, CAPA, and audit systems.
• Strong analytical and problem-solving abilities.
• Eye for detail with strong documentation skills.
• Proactive in identifying and mitigating risks.
• Experience in process validation, method transfer, and batch record review.
• Leadership, team management, and training skills.
• Strong communication and decision-making abilities.