Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Benefits: Salary: Flexible plus benefits
An independent dedicated pharma company who have an extensive portfolio of products which are used within the pharmaceutical and hospital industry. They are now looking to strengthen by adding a highly-skilled professional who can pioneer and supervise a Quality and Compliance Department.
HEAD OF QUALITY/QP
Location: East Anglia
Salary: Flexible plus benefits
Our client is an independent dedicated pharmaceutical company who have an extensive portfolio of products which are used within the pharmaceutical and hospital industry. They are now looking to strengthen by adding a highly-skilled professional who can pioneer and supervise a Quality and Compliance Department.
Responsibilities (to include, but not limited to):
* Manage the Quality and Compliance Department and providers for the company which will ensure that as a business they are fully compliant in regards to maintaining quality standards within GCP, GDP and GMP commitments.
* Full responsibility for the Compliance and Quality activities for the business, whilst liaising effectively with the EU Quality team.
* Assume control of the Site Subject Matter Expert role, communicating effectively with internal and external customers in regards to batch certification and all other relevant topics.
* Oversee Regulatory Authority Inspections
* Act as a Responsible Person as per requirements ensuring that the situations of any licenses are achieved and the guidelines of GDP are fulfilled.
* To control and pioneer the companies Quality Management System.
* Undertake external audits of existing contract manufacturers and vendors for all new suppliers, providers and manufactures respectively.
* Assess all completed manufacturing and packaging documents to efficiently ascertain that each batch has been created, verified and packed in accordance with the directives and any authorisations.
* Manage the tech-transfer of new products, from the groundwork and appraisal to the transfer of protocol.
* Coordinate with the MHRA and the Medicines Inspectorate to guarantee that the company conforms to the necessities of GMP, Manufacturing and Product Licences.
* Knowledge of Global regulations and quality control techniques
* Degree level of relevance
* Proven background in Product release compliance
* Ability to self-audit for improved performance
* Knowledge of Pharmaceutical Production
* Evidence of cross functional working
* Knowledge of Obtaining/Preserving manufacture's/Importers Licenses.
* Registered QP (desirable)
* Knack of coaching individuals for improved performance and productivity (desirable)
If you are interested please contact:
Leon Owusu on +44 (0) 0207 822 1710
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted, you have not been successful on this occasion.
Key Words: GMP, GCP, GDP, QA, Quality Assurance, QMS, RP, Inspections, QP, Audit, Batch Release, Batch Certification, MHRA, Compliance, QMS, Manufacturing, Responsible Person, Qualified Person, Quality Management Systems, East, East Anglia
3rd floor 33 Blagrave Street Reading
|Tel:||+44 (0)118 9522 797|
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