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Head of Quality Assurance
Head of Quality AssuranceInnovassynth • Khopoli, Maharashtra, India
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Head of Quality Assurance

Head of Quality Assurance

Innovassynth • Khopoli, Maharashtra, India
4 days ago
Job description

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.
  • Create a job alert for this search

    Quality Assurance • Khopoli, Maharashtra, India

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