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- Aufgaben: Lead GMP document updates and manage manufacturing compliance for Bulk and Packaging Operations.
- Arbeitgeber: Join a leading pharmaceutical company focused on quality and innovation in manufacturing.
- Mitarbeitervorteile: Enjoy competitive pay, career growth opportunities, and a collaborative work environment.
- Warum dieser Job: Make a real impact on product quality while working with a dynamic team in a fast-paced industry.
- Gewünschte Qualifikationen: Requires a BS/MS in Engineering and 8 years of relevant experience in pharmaceutical validation or packaging.
- Andere Informationen: Fluency in French and English is essential; strong communication and problem-solving skills are a must.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Overview
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.
Responsibilities
- 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.
Qualifications
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
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Specialist, Manufacturing Compliance Arbeitgeber: WuXi AppTec Group
Kontaktperson:
WuXi AppTec Group HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Specialist, Manufacturing Compliance
✨Tip Number 1
Familiarize yourself with the specific GMP regulations and guidelines mentioned in the job description, such as 21 CFR part 11 and EU-GMP guidelines. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in manufacturing compliance. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss your experience with CAPA processes and how you've successfully led investigations in the past. Be ready to share specific examples that highlight your problem-solving skills and ability to work under pressure.
✨Tip Number 4
Showcase your project management skills by discussing any relevant projects you've led or participated in. Highlight your ability to manage stakeholders and drive continuous improvement initiatives, as these are key aspects of the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Specialist, Manufacturing Compliance
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Specialist, Manufacturing Compliance position. Highlight key responsibilities and qualifications that align with your experience.
Tailor Your CV: Customize your CV to reflect relevant experience in pharmaceutical validation, packaging, or related fields. Emphasize your knowledge of GMP regulations and any direct experience with Health Authority inspections.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your understanding of the role and how your skills meet the company's needs. Mention specific examples of your experience with GMP documentation and cross-functional teamwork.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are clear, concise, and free of typos to make a professional impression.
Wie du dich auf ein Vorstellungsgespräch bei WuXi AppTec Group vorbereitest
✨Know Your GMP Regulations
Make sure you have a solid understanding of current international regulatory regulations and cGxP requirements. Be prepared to discuss how these regulations apply to bulk and packaging operations, as well as your experience with them.
✨Demonstrate Problem-Solving Skills
Prepare examples of how you've identified problems in manufacturing processes and the steps you took to resolve them. Highlight your analytical and deductive skills, as these will be crucial for the role.
✨Showcase Your Communication Abilities
Since strong verbal and written communication skills are essential, practice articulating your thoughts clearly. Be ready to discuss how you've effectively communicated with cross-functional teams in the past.
✨Familiarize Yourself with PAS-X System
As the role involves batch record creation and revision in the PAS-X electronic system, it’s beneficial to familiarize yourself with this system. If you have prior experience, be ready to share specific examples of how you utilized it in your previous roles.
