The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she is the manufacturing referee for the batch record creation and revision in PAS-X electronic system.

Experience / Education   

• BS/MS in Engineering/Technical discipline or equivalent experience
• 8 years' experience in pharmaceutical validation, packaging 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
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
• Well-developed ability to constructively work across functional areas and levels to achieve results,
• Strong verbal and written communication skills,
• Strong analytical, problem solving, influential and deductive skills,
• Capability to work with short deadlines and simultaneous activities,
• Excellent organizational and project management skills,
• Successful experience in direct people management,
• Fluent in French and English

• 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.
• Lead risk assessments and risk management cross functional teams (from draft to approval).
• Act as manufacturing referee for the batch record creation and revision in PAS-X electronic system: provide the manufacrturing input, perform the required testing and manufacturing execution to support batch record testing and qualification. Review and approve the batch record and associated Parameters value list (PVL) in Pas_X system.
• Perform complaint investigations linked to Manufacturing.
• Initiate, own, and follow up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
• Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
• Participate to or lead projects and initiatives as directed by the Head of manufacturing (bulk/ packaging Operations.
• Act as quality system and GMP Documentation referee for the manufacturing (bulk/packaging Ops Team and as a key Bulk/Packaging team representative for QA Ops.
• Support the Head of Packaging Operations in proactively monitoring Quality and performance metrics and in proposing improvement measures.