Naynesh Mistry at CK Science is currently recruiting for a Product Compliance Head to join a global pharmaceutical company at their site based in the East Midlands on a permanent basis.
Product Compliance Head Job Description
As Product Compliance Head, you will manage the compliance across the 3 production units, ensuring that all aspects of the handling, manufacturing and distribution of pharmaceutical products comply with the requirements of the Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements
The purpose of this Product Compliance Head position is to provide technical leadership for the site in all product quality compliance related matters and ensure operational business comply with cGMP legal and regulatory requirements.
Key responsibilities of this Product Compliance Head job will include:
- Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products at the site comply with the requirements of the Pharma Corporate Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements.
- Ensure that the local Quality System and Standard Operating Procedures are in place and that compliance with cGMP
- Ensure that a high quality of products is achieved through qualification and validation based upon quality risk analysis.
- Ensure that the QA department maintains an innovative approach based on improvement, implementation of best practice.
- Provide leadership, direction and support to the people within the QA Compliance area and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
- Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on product quality related matters is provided to the whole site.
- Ensure that all components, drug product containers, closures, in process materials, packaging material, labelling and drug products are released in accordance with the registered specifications.
- Manage complaints, recalls, counterfeits and product tampering according to the company Corporate Quality Manual.
To be considered for this Product Compliance Head position, you will have the following qualifications, skills and experience:
- A degree in Sciences or equivalent
- Experience in Quality Assurance and Quality Control and/or in manufacturing environment within the Pharmaceutical industry.
- Previous experience in API manufacture and ICH guidelines are preferred, however experience within secondary pharmaceutical manufacture will also be considered if you show the technical and managerial skills required for this role.
- Sound knowledge of pharmaceutical regulatory requirements and be familiar with international guidelines, including FDA and MHRA.
How to apply:
For more information regarding this Product Compliance Head position, please contact Naynesh Mistry at CK Science on 0114 283 9956 or email firstname.lastname@example.org. Please quote reference SH24328 in all correspondence.