Compliance Officer - Hay, United Kingdom - PCI Pharma Services

PCI Pharma Services

Verified Company

Hay, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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.

We have an exciting permanent opportunity for a Compliance Officer to join our Quality team based at our site in Hay-on-Wye.

Hours: 40 hours per week, Monday - Friday (office hours)

Main purpose of the role:

Continuous improvement and maintenance of the Pharmaceutical Quality System (PQS) by ensuring that all external (GMP, GDP, CFR 211, ICH) and internal requirements are implemented, monitored for performance/adherence and improved if required.

Daily operation of the Compliance function to support the business.

Main responsibilities:

Conduct internal audits as required
Liaise with new and existing suppliers as necessary.
Management of supplier corrective action system, investigation of supplier related problems and maintain supplier audit/questionnaire programme.
Arrange and participate in Customer Quality Audits.
Ensure that there are Technical/Quality agreements with suppliers as required.
Management of the change control system and customer complaints
Maintenance of PQS in compliance with internal procedures
Active participation in the analysis and continuous improvement of quality systems
Management of the Document Control system, coordinating the periodic review of all SOPs
Assist with new product introduction to ensure GMP and Regulatory compliance.
Set up and maintenance of Regulatory files for inspections
Manage QP audit schedule
Generation and maintenance of QP release certificates
Preparation of PQRs and maintenance of their schedule
Preparation of the Quality Management Review Meeting
Management of compliance KPIs
Manage and preform CAPA effectiveness reviews
Prepare data for local and site SQDC meetings
Support CSV activities as requested
Management of archived GMP Documentation
Complete the Item Supplier Relationship within the ERP system
Ensure you remain in a compliance status with regards to work activities

Work experience and skills required (essential):

Previous relevant experience in a quality role
Excellent knowledge of Good Manufacturing Practice (GMP)
Good numeracy and literacy skills
Good IT skills, including Word, Excel and Outlook
Excellent organisational skills and attention to detail
Ability to prioritise and to manage deadlines
Analytical with investigative skills
Report writing skills
Able to interact with clients/suppliers
Ability to establish good working relationships with a variety of people

Work experience, qualifications and skills required (desirable):

Experience of auditing
Experience within the Pharmaceutical industry
Knowledge of ISO 9001 Quality Management Systems
Knowledge of commercial product registration requirements

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._