The GMP specialist is responsible for GMP related items in BU5 and supports the BU5 organization with specialized and in-depth knowledge and skills on the GMP processes, systems and compliance. This role requires the ability to devise effective solutions while collaborating and aligning with various stakeholders.
The GMP Specialists are integral members of the broader Centre of Expertise (CoE) department. The CoE is crucial in supporting both the Operations (Ops) and New Product Introduction (NPI) departments, particularly regarding technical processes and GMP compliance (including Annex 1).The CoE plays a key role in translating the developed process to a workable process and environment for the shop floor. The CoE always works against the high-quality standards, safety and compliance regulations that are applicable for LVV manufacturing.
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Roles and responsibilities
- Review general LVV GMP documentation and delegate improvements to keep the general GMP compliance up to date.
- Write and facilitate change controls to document introductions and changes in the GMP production processes.
- Leads deviations and root cause investigations and ensures a timely follow up and completion of the non-conformance records.
- Participating/facilitate in quality risk assessments (QRA).
- Coordinating, supporting and preparing activities during internal and external audits in the role of Primary Contact, SME, scribe, or back-office lead.
- Coordinator internal batch release.
