Head of Quality Assurance

5 days ago

maharashtra, 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 & DocumentationReview 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 & ControlRelease 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 & ComplianceEnsure 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 ControlEnsure 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 QualityReview and approve RM vendor qualification/related documents.6. Training & DevelopmentEnsure 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 ResponsibilitiesImplement 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 SkillsExcellent 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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