Quality Assurance Specialist

4 days ago


Gandhinagar, India Gopani Product Systems Pvt Limited Full time

Job Title: Quality Assurance Specialist / Assistant Manager Quality Assurance

Location: Gandhinagar (GNR)

Industry: Manufacturing


Job Overview:

We are looking for an experienced Quality Assurance (QA) professional to manage and implement quality systems, ensuring compliance with regulatory and customer requirements. Exceptional candidates may be considered for the Assistant Manager position.


Key Responsibilities:

  1. Quality Systems:
  • Oversee site quality management systems and GMP document lifecycle.
  • Ensure compliance with SOPs and logbook management.
  1. Batch & Product Management:
  • Review and manage Batch Manufacturing Records (BMR).
  • Issue Certificates of Quality (COQ) and Analysis (COA).
  1. Audits & Compliance:
  • Prepare for and manage customer/regulatory audits.
  • Conduct internal audits, manage CAPA, and validate actions.
  1. Vendor & Training Management:
  • Conduct vendor audits and manage supplier relationships.
  • Plan and deliver QA process training sessions.
  1. Documentation & Reporting:
  • Prepare quality metrics, manage complaints, and execute review meetings.


Qualifications:

  • Graduate/Postgraduate in Science (Chemistry, Biology, Microbiology, Biotechnology) or B. Pharm/M. Pharm.
  • 4-7 years of QA experience in Pharmaceuticals or Equipment Manufacturing industries.


Key Skills:

  • Expertise in technical writing, SOP creation, and documentation.
  • Proficiency in RCA, CAPA, and audit handling.
  • Strong communication and cross-functional collaboration skills.
  • Detail-oriented and capable of managing multiple tasks.


Why Join Us?

  • Career growth opportunities in QA.
  • Work with a dynamic, innovative team.
  • Contribute to high-quality standards in a reputed organization.



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