Senior Specialist, Quality Assurance
2 months ago
**We are growing, grow with us**
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
**Senior Specialist, Quality Assurance**
**Your Job**
The part-time position is responsible for the following tasks in the UK:
- Contributing to the maintenance of the overall Quality compliance of PharmaLex UK
- Set up and monitor processes that ensure the organisations Quality Management System (QMS) conforms to customer, internal, ISO 9001 and regulatory/legal requirements
- Achieve Quality Assurance Operation Objectives by contributing information, identifying critical control points and preventative measures and analysis to strategic plans and reviews
- Set up and maintain controls and documentation procedures for functions of Quality Assurance
- Review of internal processes, especially those that affect the quality of the organisation’s products
- To establish the procedures using controlled documents such as SOPs, WIs and WPs
- Review of the training records for all employees
- Report to senior management on the performance of the QMS (e.g. results of quality audits, corrective actions, deviations and complaints), including the need for improvement
- Coordinate periodic management review meetings
- Responsible for handling external audits as required
- To facilitate internal audits and vendor qualifications
There is an option to add some additional tasks, working in the global Quality Assurance team (for the remaining 15 hours a week) if a full-time position is desired. The Main tasks for the global part of the role are as follows:
- Manage and support Client/Health authority Audits and Inspections (Organising / Backoffice)
- Provide support and knowledge on QA topics to internal stakeholders, especially those needed for representation of QA towards clients and authorities in audits: Deviation and CAPA management, KPIs, Global and local SOPs, Trainings
- Support eQMS (document up/download, training matrix, CAPA management)
- Support and develop VDC-specific-SOP writing, incl. revision
- Manage and optimise QA processes in collaboration with global QA
**Your Profile**
- Graduate/post-graduate/doctorate degree in life sciences/pharmacy/medical sciences or equivalent degrees
- Some experience relevant to the role or related industry experience
- Comprehension of Quality Assurance
- Knowledge of ISO requirements
- Ability to analyse and solve problems and to develop possible solutions
- Ability to represent the company towards external clients
- Resilient and flexible
- Excellent written and verbal English communication skills
- Ability to work in a team
**We offer**
- Competitive salary and benefits package
- 25 days holiday plus bank holidays (increasing to 27 after qualifying service)
- 8% employer pension contribution
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
For further information please don’t hesitate to contact us:
**Helen Pietropaolo**
**Manager, Human Resources UK**
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