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Quality Assurance Compliance Specialist

2 months ago

Vadodara, India SUN PHARMA Full time

Job Summary


Responsible for working with the North America Sites Quality team (Ohm, Billerica, SPCI) for preparation, review, trend, monitor quality related activities and documents. This individual shall perform multiple assignments simultaneously while working independently, with site stakeholders as appropriate.


Area Of Responsibility


  • Collation of data and drafting the Annual Product Reviews
  • Work with North America manufacturing sites to help complete the Product Quality Complaint records in TrackWise System.
  • Collate and prepare PQC trend reports for products and trending on defined frequency as per SOP.
  • Perform gap assessments of site SOPs vis-à-vis the global documents and derive actions required for revision of site SOPs.
  • Support the North America sites for routine revision of SOPs.
  • Support the North America site in assessment and mitigation of global actions in a timely manner.
  • Perform assessment and review of annual batches on stability for batches manufactured at different sites and imported by Sun Canada for distribution in Canada market.
  • Any additional work assigned by the reporting manager to support North America Cluster.


Work Conditions:

  • Corporate Office Environment
  • Manufacturing / Production Environment
  • Laboratories


Physical Requirements:

  • Ability to navigate office, lab and/or plant floor working environments, stands, ambulates, and reaches.
  • Must be capable of bending and lifting, moving and/or carrying up to approximately 50 pounds.
  • Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.

Travel Estimate: Up to 10%

Education and Job Qualification

  • Minimum of Master’s degree preferred.
  • Role supporting seminars and courses are an asset.
  • Thorough understanding of GMPs, specifically those relating to good documentation practices, quality management system, complaint handling, etc.
  • Ability to work effectively in an international multicultural matrix organization
  • Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, TrackWise, Document Management System, LMS (Learning Management System) etc.
  • Strong communication, interpersonal and organizational skills
  • Fluency in English language will be required.


Experience

  • Minimum of five (5) years of experience within the pharmaceutical industry