Biocon Ltd – Urgent job openings for Manager Quality Assurance – Central Compliance

Biocon Ltd - Urgent job openings for Manager Quality Assurance - Central Compliance

Job openings @ Biocon

Department: Quality Assurance (Central Compliance)
Designation: Manager
Qualification: B.Pharm/ M.Pharm
Experience: 12 – 16 years
Job Location: Bangalore
Job Description:
Job role – Central Compliance

  • Implementation of company’s Quality policy and GMP Regulations at all sites.
  • Overall monitoring of quality activities in the area of operation.
  • Coordinating with team members for achieving quality requirements.
  • Conduct internal GMP rounds, review of gaps and implementation of action plan.
  • Implementation of compliance actions towards Health authority observations from various audits on other industries at Biocon
  • Handling of Customer / Regulatory Audits, preparation and implementation of CAPA
  • Handling of Vendor audits.
  • Preparation and approval of QMS procedures at corporate
  • Review of Investigations – OOS, OOT, Deviations, Complaints, Recalls
  • Change management and CAPA management at Corporate
  • Review of Validation documents for Process, Methods and Cleaning
  • Design and commissioning of facilities
  • Review and implementation of Equipment qualifications and CSV
  • Training of company personnel in Quality Management Systems.
  • Implementation and monitoring of Data integrity practices
  • Engage in various consultant activities for compliance management
  • Implementation of lean management, operational excellence and statistical process control strategies and projects
  • Implementation and monitoring of enterprise level quality management projects.

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