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Asence Pharma Pvt Ltd

1 year

Vadodara

B.Pharm / BSc / Life science

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Job Title: Quality Assurance Officer/Executive
Location: Ranoli, Vadodara

Job Summary:
We are seeking a dedicated and experienced Quality Assurance professional for our Pharma API manufacturing division. This role is crucial in maintaining and enhancing the quality management system to ensure the production of Active Pharmaceutical Ingredients (API) meet the highest standards of quality, safety, and efficacy. The ideal candidate will ensure compliance with regulatory guidelines and industry best practices to support our manufacturing processes.

Key Responsibilities:

  • Oversee testing of APIs to ensure compliance with predefined quality specifications.
  • Coordinate or conduct analytical testing and stability studies for APIs.
  • Review raw materials and finished product specifications, as well as test results.
  • Ensure strict adherence to GMP (Good Manufacturing Practices), ICH (International Council for Harmonisation), FDA, EMA, and other relevant regulatory requirements.
  • Manage validation activities for equipment, systems, and processes.
  • Prepare, review, and approve documentation related to production and testing of APIs.
  • Lead or assist in managing deviations, investigations, and corrective actions to resolve non-conformities.
  • Conduct internal audits of production facilities, processes, and systems.
  • Support preparations for external regulatory inspections.
  • Stay updated on current industry regulations, guidelines, and advancements in QA practices.
  • Actively participate in risk assessments and the development of mitigation plans.
  • Train and mentor staff on QA protocols, GMP guidelines, and regulatory requirements.
  • Apply knowledge of quality management systems (QMS) and risk management tools (e.g., FMEA, CAPA).

Required Qualifications:

  • Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or a related scientific field.
  • Proven experience in Quality Assurance in the pharmaceutical industry, especially in API manufacturing.
  • Strong knowledge of GMP, FDA, EMA, and other global regulatory guidelines.

How to Apply:
Interested candidates are encouraged to submit their resume to hr@asence.com with the subject line “Quality Assurance Officer/Executive”.

Asence Pharma Hiring Quality Assurance