HomeHead/VP/CEO/President/GMLead - Quality Assurance | Encure Pharmaceuticals | Pune

Lead – Quality Assurance | Encure Pharmaceuticals | Pune

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Our Company was incorporated as Emcure Pharmaceuticals Private Limited on April 16, 1981, as a private limited company under the Companies Act, 1956. Our name embodies our purpose and core belief of the entire company which is to make Effective Medicine to Cure patients for enabling them to lead healthier lives.

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We are a fast-growing Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally. Our core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.

We are ranked as the 12th largest pharmaceutical company (Source: AIOCD Jan MAT 2017) in India in terms of market share based on the domestic sales of pharmaceutical products. We believe that our competitive advantage in the domestic market lies in our Established presence in all major therapeutic areas including blood-related, cardiology, pain and analgesics, HIV, gynecology, nephrology, anti-infective, vitamins, minerals, and nutrients products. We have also recently entered the oncology, diabetes & neuroscience therapeutic areas.

We focus our research and development efforts on developing a portfolio of differentiated
products across several platforms, including chiral molecules and biosimilars, and novel drug delivery systems. We have a portfolio of 11 chiral molecules, eight of which we launched for the first time in India. We also have the capability to develop complex products, including difficult iron preparations, oncology drugs, and controlled release products.

Position: Process Engineer – Technology Transfer

Location: Pune, Maharashtra, India

Job Description:

  • To ensure Safety, Quality, Data Integrity, and Ethical conduct policy is being implemented.
  • To ensure quality systems and standards are implemented & maintained.

     

  • Review/ Approval of Change Control, CAPA, Deviation, Investigations.

     

  • To participate in regulatory Inspections, Technical audits, Self-Inspections, Vendor Qualification & Audits, and monitoring of compliance with cGMP requirements.

     

  • To approve or reject starting materials, Packaging materials, intermediate, bulk, and finished products in accordance with their specifications.

     

  • Review and approval of Analytical Method Validation/Method Transfer data, Laboratory Instrument, Calibration reports, Qualification documents, and process validation protocol/reports and Stability documents.

     

  • Review and Investigation of Market Complaints.

     

  • Document control, Issuance & Archival.

     

  • To escalate non-conformities observed in plant and discussion of quality problems with senior management.

     

  • Responsible for compliance with technical or regulatory requirements related to the quality of the finished product and the approval of the release of the Finished products.

     

  • Review and approval of Certificate of Analysis, Standard Operating Procedures, Annual Product Quality Review.

     

  • Co-ordination between production, Warehouse, Engineering, EHS, HR, Purchase, Regulatory, R & D Lab., Compliance cell, IT-QA contract giver for regulatory submissions.

     

  • Monitoring of Technical Agreements.

     

  • Training to Employees.

     

  • To ensure Safety, Quality, Data Integrity and Ethical conduct policy is being implemented
  • To perform Job responsibilities of Superior /Counterpart in their absence.

Qualification: M.Pharm/M.Sc

Experience: 20-25 Years

Salary: Negotiable

Contact Details:

corporate@emcure.co.in, suchita.lokhande@emcure.co.in

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