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Development Quality Assurance Lead

3 weeks ago

Hyderabad, Telangana, India Aurigene Pharmaceutical Services Limited Full time
Development Quality Assurance Lead

The role of the Development Quality Assurance Lead at Aurigene Pharmaceutical Services Limited is a critical position that requires strategic leadership and technical expertise in quality assurance. The successful candidate will be responsible for ensuring that all quality systems, corporate guidelines, and new initiatives are implemented, monitored, and continuously improved.

Key Responsibilities
  • Implementation and Monitoring of Quality Systems: Responsible for the implementation, monitoring, and continuous improvement of quality systems, corporate guidelines, and new initiatives at APSL.
  • Review and Approval of Standard Operating Procedures: Review, approve, and implement Standard Operating Procedures/ Guidelines/Policies and change control Documents.
  • Laboratory Compliance: Ensure the laboratory remains in compliance and inspection-ready at all times.
  • Incident Investigations and CAPA: Facilitate effective incident investigations in a timely manner and implement Corrective Action Preventive Action (CAPA) for all APSL projects and general incidents within APSL.
  • Customer Quality Agreements: Negotiate, approve, and monitor customer quality agreements and ensure compliance.
  • New Business Partner Qualification: Participate in the qualification of new strategic Business partners (SBPs) by following established procedures, including auditing and approving quality agreements with SBPs.
  • Customer Interaction: Engage with customers, respond to their queries, and provide appropriate details.
  • Technology Transfer: Facilitate the quality team to achieve successful technology transfer of new products to manufacturing plants and support Regulatory Affairs team for DMF filing and regulatory deficiency response.
  • Gate Clearance Support: Verify gate clearance documents of the HPT and guide/support other DQA members for technical evaluation of their gate clearance documents.
  • Regulatory Audits and Customer Audits: Support respective plants during regulatory audits and customer audits for products developed and transferred from APSL, ensuring sufficient details on development aspects.
  • Customer Complaints Investigations: Facilitate and support internal manufacturing plants and SBPs for customer complaints investigations and closure.
  • Audits and Presentations: Perform internal and unannounced audits at APSL and SBP to ensure online compliance, review presentations, and present quality issues for management review meetings, quality review meetings, etc.
  • Training and Quality Guidelines: Provide training on cGMP, GDP, GLP, and SOPs, as well as quality guidelines and regulatory updates to other DQA members.
  • Calibration and Preventive Maintenance: Review and approve calibration and preventive maintenance schedules and ensure activities are carried out as per the schedule.
  • Data Backup and Handling: Monitor and ensure electronic data are backed up using appropriate media (CDs, DVDs, Tapes) as per the periodicity defined in respective SOP in A R&D Lab.
  • QA Activities: Handle all QA activities in the absence of Head Quality Assurance.