Senior Quality Specialist

5 months ago

Tredegar, United Kingdom PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
- To ensure the effective management of the Supplier Management Programme.
- Management of Nitrosamines Statements, Quality Agreements and TSE Statements; and ensuring periodic updates are performed by the required due dates.
- Generate Elemental Impurities Assessments.
- Management of the supplier audit schedule and scheduling supplier audits.
- Provision of vendor metrics to the global team, and participate in global vendor management discussions.
- Authoring annual Product Quality Reviews.
- The job holder is required to work on their own initiative and largely independently on key responsibilities under the supervision of the QMS Team Leader.
- The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines themselves and by team members.
- The nature of the role of the Senior QA Specialist requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.
- The role demands technical and regulatory knowledge, high standards of attention to detail and the desire to see tasks through to completion.
- A strong problem solving ability is needed to assist team members in identifying and eliminating problems. Where qualified, the job holder will also be required to train other personnel in quality system procedures and approaches.
- The job holder must command the respect of peers and co-workers and constantly uphold the company values of trust, integrity, pride, passion, enjoyment and respect in every aspect of their role.
- A high degree of influencing skills will also be required in order to gain the delivery support required from personnel over whom the job holder nay have no direct authority.
- This position has no authority for expenditure.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._

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