Company: SEC Recruitment
Closing Date: 02 Nov 16
Salary (£): Negotiable
Compliance Manager – Perm position An exciting opportunity has arisen for one global Pharmaceutical company located just north of London. This is an excellent challenge for an experienced QA professional to overlook the Quality System of an important Manufacturing site in the UK. ...
Compliance Manager – Perm position
An exciting opportunity has arisen for one global Pharmaceutical company located just north of London. This is an excellent challenge for an experienced QA professional to overlook the Quality System of an important Manufacturing site in the UK.
• Manage the Quality Compliance function to provide an efficient and effective service to support the timely release of materials, components and products, including UK Commercial and imported products controlled by the sites.
• Supported by the Quality Systems Manager and Qualified Persons, provides full Quality Assurance support to site operations.
• Undertake the duties of a Qualified Person
• Working with the site management, ensures that the UK sites operate in a fully GMP compliant manner in accordance with all of the relevant legislation, corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported
• Reports and manages performance metrics in a timely and effective manner.
• Ensures that all Quality Compliance staff are suitably empowered and fully engaged with other business functions and that appropriate processes and systems are established and maintained to ensure the efficient, effective and compliant support of site (and global) operations.
• Recruits, trains, coaches and mentors suitably qualified and knowledgeable people to ensure that they are able to carry out their duties and tasks in a compliant and safe manner in accordance with the relevant approved procedures.
• Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System. Mentors others to expand on-site compliance knowledge.
• Partners with and supports other sites and functions as needed during the technical transfer of products into and out of the site
• Acts as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections.
• Where inspections and audits of the sites are undertaken ensures that any adverse observations or findings are thoroughly evaluated and suitable CAPAs implemented and closed out in a timely fashion to fully address the deficiencies raised.
• Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
• Eligible for nomination as a Qualified Person.
• 8 years post graduate experience in pharmaceutical manufacturing either in a QA or QC role.
• 5 years supervisory or management experience
• Excellent knowledge of GMP, continuous improvement/business excellence
• Excellent interpersonal skills including good communication, conflict management and leadership
3rd Floor, 13-15 Moorgate London.
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