Role: RP / Quality Manager - Pharmaceutical
Location: West Yorkshire
Russell Taylor Group has a fantastic opportunity within a leading pharmaceutical manufacturing company working as an RP / Quality Manager. You will support the management and oversight of the GMDP / QMS and ensure that products supplied by the company are manufactured, distributed and released in compliance with applicable laws/regulations and the respective Marketing Authorisation.
- You will manage and own QMS records, continuous improvement and inspection readiness activities.
- Train, educate, coach, mentor support department members and other Affiliate(s) personnel.
- Perform disposition/certification of Affiliate(s) products.
- Perform the relevant activities required to fulfil the duties of the Qualified Person as per Eudralex Volume 4 and the QP Code of Practice.
- Inspection of samples and archive as required.
- Support QP Declaration regarding API as required.
- Support Affiliate(s) QP batch release process as required.
- Perform the relevant activities required to fulfil the duties of the GDP Responsible Person as per the GDP and GMP Guidelines.
- Qualification of Suppliers / Distributors / Logistic Service Providers
- Complaint Management, Deviation / CAPA / Non Conformance Management, Bonafide Verification of Customers
- Quality Warning support, Recall Management, Out of Stock notification to the authorities and Destruction Management.
- Develops relationships with selected contractors, suppliers and partners.
- Trouble shoot manufacturing, testing and certification issues at selected contractors.
- Regulatory intelligence activities.
- Risk Identification, assessment and Mitigation.
- Life Science Degree
- Experience of working within a Quality Management System in the pharmaceutical industry
- Sound knowledge of applicable Regulations, Directives and Guidance particularly pertaining to GMDP and other GxP Practices.
- Exceptional organisational skills - ability to prioritise effectively
- Excellent oral and written communication skills, able to be effective at all levels, & effective report writing
- Good interpersonal skills - ability to work with cross-functional teams
- Good negotiating skills
- MS Office applications; including Excel; PowerPoint; Project; and Word, is required
- Accuracy and attention to detail
- Able to challenge scientific arguments - strong analytical approach to identify problem areas and identifying effective solutions
- Ability to work under own initiative - proactive problem solving approach
- Team player
- Positive 'can do' attitude
- Good understanding of business needs