Quality Assurance Manager

Zenopa

Coventry, England, United Kingdom

Coventry, England, United Kingdom

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À propos

Zenopa are excited to be working as a long-standing partner of a growing privately-owned pharmaceutical manufacturer with a diverse portfolio of products including Branded Rx, Generics, OTC and medical devices. You will be responsible for overseeing and performing the key tasks required to maintain the various Quality Assurance processes required to ensure compliant receipt and approval of incoming products from appointed Third party Contract Manufacturers. Liaise with the manufacturing sites and third party warehouse and distribution providers, to ensure all delivery and batch paperwork are provided in a timely manner and good order. To help in preparing and approving delivery paperwork to allow final release by a named QP or RP/RPi. Support in ensuring that SOPs, Technical Agreements and other Quality Documentation related to these activities are kept up to date and are followed. Lead the Deviations, CAPAs, Change Control and Risk Assessment processes. Lead the supplier quality management program and working closely with the Supply Chain Department and other cross-functional departments. Liaise with Regulatory Affairs and the respective contract manufacturing sites to ensure product license variations and any artwork changes are manage in a timely manner to ensure ongoing compliance with the MAs. Support the Head of Quality in the self-inspection program and external audits as required. Lead the ISO 13485 certification and manage the relationship between the company, the Notified Body and any contractors carrying out activities related to compliance with EU and MHRA regulations concerning medical devices.
Person Specification:
3-5 years in Pharmaceutical Quality Assurance. Eligibility to act as RP/RPi desirable but not mandatory.
TPBN1_UKTJ

Coventry, England, United Kingdom

Compétences linguistiques

English

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