This offer job is expired.

GMP Quality Manager

Novartis - Expires on Feb 13, 2015
  • Country
  • Location
  • Job Type
  • Experience
  • Eligibility
  • Thailand
  • Not specified
  • Permanent - Full Time
  • 5+ years
  • Expat and local
Function
Product Development / Management
Job Category
Pharmaceutical / Biotech / Life Sciences
Salary
Negotiable

Job Description

  • Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual/Policies and meet relevant cGMP regulatory and legislative requirements.
  • Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities; and that current knowledge & compliance with cGMP/GDP regulations is maintained through training and internal audits.
  • Establish a good working relationship with the Supply Chain Management (SCM) and DRA departments.   Coordinate with oversea manufacturing sites for quality aspects such as product defect, testing monograph.
  • Ensure that co-ordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.
  • Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process and Deviation Management are in place.
  • Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards.
  • Ensure country organization readiness for all GMP regulatory inspections.
  • Manage external inspections, Product Complaints, Recalls, Counterfeits and Product tampering according to the Novartis Corporate Quality Manual and local written procedures.

Job Requirements

  • Bachelor Degree in pharmacy or life science-related field.
  • Min. 5 year experience in pharmaceutical industry in a relevant fields such as Quality Assurance, Quality Control, Regulatory & Registration, Production, or Quality in commercial and marketing.
  • Has good knowledge in Good Manufacturing Practice (GMP), Good Storage and Distribution Practice (GDP) Fluent in both speaking and writing English.

About the recruiter

Novartis

A global healthcare leader,  Novartis  has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, ...

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