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Job Details

QA Regulatory and QMS Manager - Worthing

Company: CK Clinical
Location: Worthing
Reference: KA42692
Closing Date: 06 Aug 18
Type: Contract
Salary (£): 60,000 - 80,000

Job Summary:

Jennifer Woolley is recruiting for a QA Regulatory and QMS Manager to join a company in the Pharmaceutical industry at their site based in Worthing...


Jennifer Woolley is recruiting for a QA Regulatory and QMS Manager to join a company in the Pharmaceutical industry at their site based in Worthing on a 12 month contract basis.

As a global healthcare company, our client takes on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.

The QA Regulatory and QMS Manager will be based at our clients Worthing site, which is set in a beautiful location on the coast in West Sussex. This is a primary and secondary site that manufactures tablets and sterile liquids, specialising in antibiotic manufacture. There are around 1000 people employed at this site.

Worthing is a large seaside town in along the southern coast of England, with borough status in West Sussex. It is situated at the foot of the South Downs, 10 miles west of Brighton, and 18 miles east of the county town of Chichester with great train, car and other public transport links.
The QA Regulatory and QMS Manager is responsible for maintaining current regulatory documentation for all Worthing site processes responding to changing business and regulatory agency requirements . The role provides expert regulatory knowledge to the site through the direction of multidisciplinary teams. This roles is responsible for the QMS implementation process across site.

Additional duties include:
-Lead the maintenance of site compliance to licences/ pharmacopoeias and worldwide regulatory requirements.
-Manage the preparation and review of submissions for variations/supplements for all Worthing site products.
-Liaise with Global Post Regulatory Affairs and North America Post Regulatory Affairs to review questions from global regulators and provide and agree official responses.
-Provide expert regulatory advice critical to the development and implementation of strategic projects and for ongoing production batch destination.
-Approve Technical Terms of Supply and Technical Agreements with global markets and 3rd parties.
-Lead the setting and registration of appropriate specifications for all site products.
-Provide regulatory support for Level 3 and 4 audits.
-Manage and assess the ongoing effectiveness of the local QMS implementation process.
-Ensure QMS compliance for regulatory affairs.
-May act as Inspection readiness lead.

To succeed in this role, you will have comprehensive knowledge of worldwide regulatory requirements and current standards and formats, comprehensive knowledge of operations in areas of expertise, e.g. steriles, packaging, manufacturing, understand mechanisms involved in Pharmacopoeial monographs/test methods and General Notices and awareness of the regulatory requirements of change and impact on business processes of delays.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not heard back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42692 in all correspondence.

Apply for this job: QA Regulatory and QMS Manager - Worthing

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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