Head of Quality Assurance
5 days ago
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.
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