QA RA Manager

1 week ago

Dombivli, Maharashtra, India Lywo Hyderabad Full time ₹ 9,00,000 - ₹ 12,00,000 per year

We are seeking a detail-oriented Deputy Manager Quality Assurance to support robust QA operations and also some Regulatory Affairs functions at Acharya Group's API manufacturing unit. This role focuses on maintaining our Quality Management System (QMS) for API production, ensuring cGMP and regulatory compliance for EU, USFDA, PMDA, and other Major Regulatory Regions. Key responsibilities include participating in batch release and continuous improvement; overseeing validation of API manufacturing processes, equipment, and analytical methods, managing deviations, conducting investigations, and implementing CAPA plans. Candidates must have prior experience in Quality Assurance within API manufacturing, preferably at the level of Assistant Manager or Senior Executive, and demonstrate a proactive approach with a strong commitment to quality and compliance.

Responsibilities:

  • Lead QMS planning and implementation to ensure regulatory compliance and adherence to Acharya Group standards.
  • Review and approve SOPs for Quality Management Systems, ensuring clarity and best practices in API manufacturing.
  • Oversee document control for SOPs and BPCRs, maintaining accurate records.
  • Train plant employees on quality procedures specific to API production.
  • Review annual trending of products and intermediates to verify process and quality system consistency.
  • Assist in implementing cGMP guidelines across the Acharya Group.
  • Conduct validations (Process, Analytical Method, Cleaning) as per the Validation Master Plan for robust API manufacturing.
  • Establish and maintain equipment calibration and validation procedures.
  • Conduct vendor and internal audits to assess compliance and identify areas for improvement in the API supply chain.
  • Ensure thorough investigation, resolution, and documentation of critical deviations, implementing effective CAPA measures.
  • Conduct vendor and internal audits to assess compliance and identify opportunities for improvement within the API supply chain.
  • Manage material and vendor quality, including handling audits by USFDA, EDQM, and customer audits.
  • Review batch production and laboratory control records before releasing APIs and intermediates.
  • Perform periodic product quality reviews and conduct quality risk analysis for continuous improvement of API manufacturing.

General Expectations and Past Experiences:

  • Possess a strong understanding of cGMP regulations and guidelines related to API manufacturing.
  • Demonstrated experience in managing and leading quality assurance activities in a pharmaceutical setting.
  • Proven ability to conduct and manage process validation, analytical method validation, and cleaning validation.
  • Experience in preparing and reviewing regulatory documents such as DMF/ASMF.
  • Proficient in using Quality Risk Management (QRM) tools and techniques.
  • Excellent technical writing and documentation skills.
  • Strong leadership and communication skills, with the ability to effectively interact with cross-functional teams and regulatory agencies.

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