Research Associate, Research Executive

2 - 4 Years

Job Description

General Accountability
  • Experience of preparation of Technology Transfer Documents (TTD), QMS, Compliance, SOPs.
  • Preparation of documents for OSD (tablets/capsules/pellets) for regulatory markets.
  • Audit preparations
  • ANDA submission related documentation
  • SAP transactions

Description of the Role:
  • Preparation of Technology Transfer documents (TTDs) like batch records, qualification protocols, stability protocols for scale up/registration/intended commercial batches.
  • Preparation and issuance of site variation/ query response documents.
  • Maintain record of test licence, manufacturing licence, punch change part procurement, Master Formula Card (MFC)
  • Monitoring 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 and equipment.
  • Impart training to F&D team members on various aspects of GMP/GLP guidelines and practices.
  • Co-ordinate predefined frequencies calibration for IPQA instrument and analytical equipments and its periodic review.
  • Preparation of SOPs/Department manuals, Formulation department manual, its issuance and archival.
  • Conduct periodic review of lab note book for the experiments carried out in labs.
  • Maintenance of IQ, OQ, PQ, manuals of equipments/ instruments
  • Innovator sample management
  • Review the audit recommendations for compliance 

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:Documentation/Medical Writing

Employment Type:Permanent Job, Full Time


Desired Candidate Profile

Please refer to the Job description above


PG:M.Pharma - Pharmacy

Company Profile

Unichem Laboratories Ltd

We are a leading pharmaceutical company with an increasing focus on innovative research and developed markets. To augment our efforts in achieving our expansion and business plan we invite young and energetic people to take up responsible positions in our organisation
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Recruiter Name:HR

Contact Company:Unichem Laboratories Ltd

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