Head of Quality Assurance

4 weeks ago

Khopoli, India Innovassynth Full time

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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