Manager Quality Assurance

10 - 15 Years

Job Description

  • To ensure that each batch has been manufactured and packed in accordance with the approved manufacturing and packing procedure, complies with established specification of that product and is in accordance with the requirements of the marketing authorization.
  • To approve or reject finished products.
  •  To oversee the control of the reference and/or retention samples of materials and products wherever applicable.
  • Management of the in-process quality assurance.
  • To approve DQ/IQ/OQ/PQ data generated for each equipment/instrument/utility used for the manufacturing/packing/testing of finished drug products.
  • To approve preventive maintenance/cleaning schedule for building facility/ equipments/utilities prepared by respective department as per cGMP requirement.
  • The authorization of written procedures and other documents, including amendments.
  • Storage and maintenance of documents/records generated as per cGMP requirements.
  • The monitoring and control of the manufacturing environment.
  • To ensure that the duly filled batch manufacturing and packaging records received from production department are reviewed and only after review, batch is released for final dispatch.
  • Maintenance of plant hygiene.
  • Handling of market complaints and returned goods.
  • Training
  • The designation and monitoring of storage conditions for materials and products.
  • Retention of records.
  • Monitoring of compliance with the requirements of Good Manufacturing Practice.
  • Inspection, investigation and taking of samples in order to monitor factors which may affect product quality.
  • Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • To ensure that deviations and planned changes are handled as per the established systems and are authorised by the responsible persons.

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager


Desired Candidate Profile

Please refer to the Job description above


UG:B.Pharma - Pharmacy

PG:M.Pharma - Pharmacy

Company Profile

Unichem Laboratories Ltd

Promoted by the late Mr. Amrut Mody, a pioneer of the Indian pharmaceuticals business, Unichem Laboratories has grown to become one of India's most respected pharmaceutical companies. It is committed to deliver better health through superior products. By combining strategic research and in-depth industry knowledge, Unichem aims to transform itself into a global pharmaceutical drug Company with an increasing focus on cutting-edge research and developed markets.

With formulations constituting the core of the company business, Unichem is backward integrated to API Manufacturing, which adds value to the customer in terms of quality and sustainability.
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Recruiter Name:HR

Contact Company:Unichem Laboratories Ltd