Quality Operations Manager
Job Location:
Job Location:
Hertfordshire - UK
Salary:
Not Disclosed
Salary:
Posted on:
15 hours ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Talentmark are recruiting for a Quality OperationsManager to join a well-established and successful global pharmaceutical company based in Hatfield Hertfordshire on a permanent basis.
Role:
This role is responsible forQuality Operations and Quality Assurance activities ensuring GMP compliance and quality system support for the manufacture packaging testing storage and distribution of marketed drug products.
Key duties will include:
Your Background:
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197861 in all correspondence.
Role:
This role is responsible forQuality Operations and Quality Assurance activities ensuring GMP compliance and quality system support for the manufacture packaging testing storage and distribution of marketed drug products.
Key duties will include:
- Ensure quality system procedures and processes meet corporate regulatory and industry requirements and promote site adherence to them.
- Support site compliance activities including implementation of new GMP requirements and inspection readiness programs.
- Support and (where required) lead Quality Operations planning and provide QA oversight for QC and Production activities to enable timely batch review release and distribution.
- Perform batch review of site and non-site manufactured batch records as required.
- Monitor and report Quality Management System performance metrics and KPIs. Input and lead Quality Management Review meetings (as required.)
- Represent Quality Operations during regulatory inspections customer audits and third-party audits and support internal and external audit programs.
- Lead the Product Quality Review (PQR) program including trend analysis and reporting.
- Author review and approve SOPs and other quality documentation such as PQRs deviations complaints investigations CAPAs change controls and qualification/validation documentation.
- Maintain and enhance the TrackWise Quality Management System ensuring compliance with GxP and electronic records requirements.
- Deliver GMP and quality systems training coaching and mentoring to site personnel.
Your Background:
- Educated to degree level or above in a science discipline with extensive previous experience in a Quality Management or Quality Assurance leadership role within the pharmaceutical industry.
- Extensive knowledge of Quality Assurance Quality Systems GMP GDP and pharmaceutical manufacturing and packaging processes.
- Experience with overseeing maintaining and improving Quality Management Systems.
- Strong understanding of global GMP regulations and guidelines with the ability to interpret implement and maintain compliance requirements.
- Proven ability to build effective relationships and collaborate across functions sites affiliates and external partners.
- Strong communication and influencing skills with the ability to engage stakeholders at local regional and global levels.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 197861 in all correspondence.
About Company
Idibu
100 employees
Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more
