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.