Snr QS Associate
A leading pharmaceutical client is searching for a Senior QS Associate to join their team in teh UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. The Senior QS Associate will be responsible for ensuring that operations carried out within the Quality Systems section are completed in accordance with the requirements of internal Quality System and Standard Operating Procedures.
- Preparing, reviewing and maintaining quality policies and procedures associated with Product Quality Reviews, Quality Agreements, Complaints, Change Control, Deviations and CAPA, Training, Internal and External Audits, Standard Operating Procedures, Parallel Imports and Approved Supplier activities to form part of the internal Manufacturing Limited (EML) Quality System.
- Support the Quality Systems Manager in the management of the Regional Quality System for the Europe, Middle East and Africa (EMEA) region, ensuring that products are managed and distributed in line with the Regional Quality System Procedures.
- Responsible for supporting the effective running of the Quality Systems
- Represent the Quality Operations department on assigned Project Teams to provide a consistent approach to the formulation, preparation and execution of quality actions and to also ensure that these activities are performed in a controlled manner in line with current GMP and internal Corporate expectations.
- To support the management of the Quality Agreement, Product Quality Review, Complaint, Change Control, Qualification and Validation, Deviation, Training, Internal and External Audit, Standard Operating System, Parallel Imports and Supplier Approval systems.
- To support the generation of Quality Systems procedures to meet internal corporate, pharmaceutical industry and GMP expectations.
- To support the ongoing operation, maintenance and implementation of improvements to Track Wise processes and systems to meet EMLs needs.
- To support the maintenance of current Regulatory Information to support product release
- To maintain copies of Corporate Policies, Guideline, Standards and Procedures.
- To write and review SOPs associated with Quality Management Systems
- To participate in audits of EML (internal and external).
- To participate in audits of external suppliers of products and services for EML and EMEA internal companies.
- To support Quality Systems training of EML staff, as required.
- To coordinate and support GMP Training.
- To provide day to day support to other members of the Quality Systems team, as appropriate.
- To provide training and mentoring to other members of the Quality Systems Team or EML personnel
- Identify and implement continuous improvement opportunities that result in cost savings and more efficient and compliant ways of working.
- To support the management of the Regional Quality System procedures and processes.
- To support the generation of Quality Management Systems Indicator reports.
- To deputise for the Quality Systems Manager, when appropriate.
- To perform any appropriate duties at the request of the Quality Systems Manager.
Skills and Requirements:
- Able to maintain working relationships and communication links within EML, affiliated organisations and third-party contractors.
- Extensive knowledge and experience of Quality Assurance, Quality Systems, GMP and an understanding of manufacture and packaging of pharmaceutical products.
- Good technical and scientific judgement.
- Diplomatic, self-motivating, professional with problem solving and decision-making capabilities.
- Good communication skills at all levels and in an appropriate way.
- Developed presentation skills.
- Computer literate e.g. Word, Excel and PowerPoint.
- Project management skills and able to prioritise work plans and multitask.
- Ability to interpret and translate GMP Guidelines into effective procedures.
- Able to act as a mentor in support of staff development.
- Demonstrate initiative and creative thinking.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on or upload your CV on our website - .
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.