Research Associate / Executive – Formulation Development

2 - 5 Years

Job Description

  • To prepare technology transfer documents (TTD) like, batch records, qualification protocols stability protocols for scale up/ registration / intended commercial batches
  • Preparation and issuance of site variation/ query response documents
  • Maintain the record of test License, manufacturing License, punch change part procurement ,Master formula card (MFC)
  • To monitor proper transfer of documents from R&D to plant QA
  • To review and approve change control, deviations and implementation of changes to meet the compliance
  • To co-ordinate predefined frequencies calibration for IPQA instrument & Equipment
  • Impart training to F&D team members on various aspects of GMP/GLP guidelines and practices
  • To co-ordinate predefined frequencies calibration for IPQA instrument & analytical Equipment's and its periodic Review
  • Preparation of SOPs/Department Manuals, Formulation department manual and its issuance and its archival
  • To review periodically lab not book for the experiment carried out in labs
  • Maintenance of IQ,OQ and PQ, manuals of equipment/ instruments and update
  • nnovator sample management
  • Review the audit findings observations recommendations given in the audit report for compliance

Required Candidate profile

  • Experience of preparation of technology transfer documents (TTD), QMS, Compliance,  SOPs
  • Must have working experience to prepare documents for OSD (tablet/ capsules/ pellets) for regulatory markets
  • Audit preparations
  • ANDA submission Documents preparation
  • Hand on experience on SAP
  • Quality Compliance

Salary: Not Disclosed by Recruiter

Industry:Pharma / Biotech / Clinical Research

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

Role Category:R&D

Role:Bio/Pharma Informatics-Associate/Scientist


Desired Candidate Profile

Please refer to the Job description above

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