The Specialist, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. This includes batch record master creation and revision.

He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required.

Experience / Education    

• BS/MS in Engineering/Technical discipline or equivalent experience
• 2 years' experience in pharmaceutical validation, manufacturing or related field

Knowledge / Skills / Abilities: 

• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
• Knowledge of pharmaceutical manufacturing processed
• Capability to work with short deadlines and simultaneous activities,
• Fluent in French and English
• Excellent knowledge for pack office especially Word

• Author paper master batch record for the assigned new product. Ensure that content is aligned with the process flow and gap analysis and ensure that the content is suitable for the production team (ensure that sequence is suitable, wording is clear and not confusing)
• Revised assigned batch record following production, QA, MS&T and customer feedback
• Initiate deviations and participate to or lead on the floor investigations. Partner with QA and Packaging or Bulk Operations to ensure assessments and investigations are exhaustive.
• Follow up and implement assigned CAPA's.
• Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, Forms and logbooks. Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
• Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.