On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a
Engineer Manufacturing & Compliance
Vos tâches
Position Summary
The Engineer Manufacturing & Compliance authors, owns and leads updates of GMP documents/projects related to Bulk, Packaging and/or Warehouse Operations. He/she initiates and owns deviations assessments and participates to investigation tasks as required. He/she supports the Head of Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation, and training.
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He/She supports and leads projects with the GMP activities (change control, URS, Protocol, etc…)
Duties/Responsibilities
Initiate deviations and participate to on the floor investigations. Partner with QA and Boudry Packaging Operations to ensure assessments are exhaustive.
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Follow up and implement assigned CAPA’s.
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Author and review manufacturing documents, including specifications, working practices, SOPs, forms and logbooks. Follow up approval flow within electronic documentation system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
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Lead or Support manufacturing projects (new equipment, process change, etc…) by managing the documentation associated with the project (URS, Protocol, Change Control, etc…)
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Lead risk assessments, data integrity risk assessment and risk management within cross functional teams (from draft to approval).
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Maintain all risk assessments up to date
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Perform complaint investigations.
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Manage the defect library process and the related training for the site.
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Initiate, own, and follow up change controls related to manufacturing (bulk/packaging). Manage stakeholders involved.
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Ensure distribution and withdrawal of GMP documents in manufacturing area.
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Contribute to continuous improvement, including proactively identifying problems, gathering input from the operational team and proposing solutions.
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Participate to or lead projects and initiatives as directed by the Packaging Operations management.
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Participate or lead technical aspects for specific projects (SAT, FAT, Technical visit at the supplier or on site) to bring technical expertise.
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Act as quality system and GMP Documentation referee for the Manufacturing Packaging Ops Team and as a key representative for QA Ops.
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Support the team in proactively monitoring quality, safety and performance / reporting metrics (OEE, Tier Meeting) and in proposing improvement measures.
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Act as the back up of other Engineer Manufacturing & Compliance in Bulk and Warehouse departments.
Reporting Relationship
This position reports to the Senior Manager, Support Manufacturing
Votre profil
Qualifications
BS/MS in Engineering/Technical discipline or equivalent experience.
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7 years’ experience in pharmaceutical validation, packaging, drug manufacturing process or related field.
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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
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Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
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Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
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Well-developed ability to constructively work across functional areas and levels to achieve results.
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Strong verbal and written communication skills.
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Strong analytical, problem solving, influential and deductive skills.
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Capability to work with short deadlines and simultaneous activities.
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Excellent organizational and project management skills.
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Fluent in English and in French.
Langues
Fluent in English and in French.
Date d'entrée
À convenir