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- Competitive Salary
- Flexible Working
About Our Client
A privately owned global pharmaceutical company with operations through over twenty fully-owned affiliated companies around the world. The Company is a world leader in novel therapies for gynaecology and andrology.
Job Description
Digital Quality Management System
- Implementation, maintenance and administration of new eQMS at corporate level.
- Work with IT department to support validation activities of the eQMS.
- Introduction of quality related modules in eQMS (documentation, training, change controls, CAPAs).
- Integration of eQMS platform via building eQMS community in the organisation, as Quality Subject Matter Expert to deliver related trainings.
Documentation System
- Identify and drive improvements/updates to the GXP documentation.
- Lead implementation of Global documentation for manufacturing activities.
- Work on harmonisation of processes and participate in improvement initiatives.
Audits Management
- Act as a real partner in corporate audit programs (internal and external)
- Manage auditors' qualifications, auditors community
- Identify improvement of cross functional audit, related CAPAs, applicable KPIs
The Successful Applicant
Profile
- Pharmacist or Engineer with Master's degree or Bachelors in Quality, Regulatory.
- 3 to 5 years of experience in pharmaceutical or biotechnology industries.
- Experience working with electronic Quality Management System a mandatory.
- Relevant experience in either quality (regulatory, manufacturing, or development).
- Understanding of GxPs, quality systems and regulations (EU, FDA and knowledge of Japanese or other geographies' regulations is a plus).
- Knowledge and interest in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Good communication skills
What's on Offer
- Competitive Salary
- Flexible Working
- Opportunity for progression and professional development
Contact
Meg Spillane
Quote job ref
JN-062022-5660810
Phone number
+44 207 269 2278
Job summary
- Sector
- Life Sciences
- Subsector
- Quality
- Industry
- Healthcare / Pharmaceutical
- Location
- International
- Contract type
- Permanent
- Consultant name
- Meg Spillane
- Consultant phone
- +44 207 269 2278
- Job reference
- JN-062022-5660810
