Quality Manager- CMO- Global Pharmaceutical

Recruiter
Vantage Recruitment Solutions Ltd
Location
Hounslow, UK
Salary
Competitive
Posted
10 Jun 2019
Closes
18 Jun 2019
Ref
1176844365
Contract Type
Permanent
Hours
Full Time
Quality Manager | CMO | up to €65k | Hounslow | Global Pharmaceutical Company | Life Sciences

This small but rapidly growing global pharmaceutical company has a great opportunity for an experienced Quality Manager - CMO to join their fledgling quality team. The team is currently quite small but is expected to grow massively over the next 3-5 years, offering tremendous potential for career growth and internal promotion. This is an excellent opportunity for someone that has excellent QA experience and CMO experience that is looking to step up into a Manager position.

Quality Manager | CMO | up to €65k | Hounslow | Global Pharmaceutical Company | Life Sciences

Responsibilities and Key Tasks
  • Ensure documentation and processes are compliant and effective across CMOs, including and not limited to:
  • QMS and data integrity
  • Vendor and supply chain management including due diligence on new projects
  • Batch Manufacture Testing and Release as applicable
  • Recall Management
  • Product Quality Reviews
  • Stability Programs
  • Quality issues management: deviations, OOS, CAPA, complaints, change management
Support the technical transfer and new product introduction projects to transition acquired products into the PCC EU portfolio.QA related tasks related to third party CMO ensuring that CMOs perform tasks and duties in compliance with GMP/GDP and PCC EU standards.Ensure adequate QA oversight and adequate GMP compliance at the CMOs sites for new and current products including process validation, master documentation approval and the implementation of quality agreements.Participate in EU GMP/GDP inspections and provide support in preparation/readiness and post inspection compliance reports/interim update reports PCC EU and third party CMO sites.Support the management and governance of PCC EU Quality Operations to ensure compliance with GMP/GDP and Marketing Authorizations.Participating and contributing Management Review Meetings across PCC EU sites.
Key Skills
  • Good technical knowledge of EU GMP, regulations and guidelines. Experienced in the operation of an EU regulatory approved QMS.
  • Highly collaborative, regular interaction with the named QP, Regulatory groups, QPPV, Supply chain, site-based QA, distributors, testing labs, warehouses, sales departments, customers, MA holders and regulators.
  • GMP auditing knowledge and practical skills, both hosting and performing.

Qualification Requirements
  • Minimum a BCS degree in life science.
  • Minimum 5 years' experience in a similar Quality Assurance role within the Pharmaceutical Industry
  • Minimum 2 years' experience gained through batch review
  • Relevant GMP training as required to discharge assigned duties and responsibilities

Working Conditions

Office based working environment, availability to travel up to 35% of the time

As Quality Manager you will be reporting into the Quality Manager - Operations, Europe.

Quality Manager | CMO | up to €65k | Hounslow | Global Pharmaceutical Company | Life Sciences

This job was originally posted as www.totaljobs.com/job/86809964

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