HAY_Compliance Officer Hay, Wales
PCI Pharma Services
Full Time
Hay, Wales
20000 - 24792 GBP ANNUAL Today
Job 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.
Our Quality team have a fantastic opportunity for a Compliance Officer to join the team at our Hay Site. If you are an effective rapport builder who is conscientious, reliable and team-minded with a willingness to learn & develop then we would like to hear from you!
In return, we can offer you a competitive employee benefits package and a great working environment which will provide you with a wealth of opportunity to thrive!
Main purpose of role:
The Compliance officer will play an integral role in ensuring the efficient and diligent operation of the business compliance function. You will be responsible for the continuous improvement and maintenance of the Pharmaceutical Quality System (PQS) and ensure that our external and internal regulatory requirements and processes are executed, understood and followed. You will also be responsible for making and implementing recommendations for improvement as appropriate to ensure operational excellence is adhered to at all times.
Responsibilities include (but are not limited to):
- Management of the change control system and customer complaints
- Maintenance of the Pharmaceutical Quality system in compliance with internal procedures
- Management of the Document Control System and coordinating the periodic review of all Standard Operational Procedures (SOPs) across the site
- Set-up and maintenance of regulatory files for inspections
- Manage the audit schedule for QP’s (Qualified Person)
- Management and achievement of Key Performance Indicators (KPI’s) for compliance
- Collation and preparation of data for local and site briefings in-line with the sites strategic objectives
- Manage and perform reviews of CAPA (correct and preventative actions) effectiveness and suggest improvements as appropriate
- Management of archived GMP (Good Manufacturing Practice) documentation
- Ensure you remain in a compliance status at all times regarding your work activities
- Generation and maintenance of Qualified Person (QP) certification
- Preparation of Product Quality Review (PQR) and maintenance of their schedule
- Active participation in the analysis and continuous improvement of quality systems and making recommendations for improvement as appropriate
- Liaise with new and existing suppliers and build up effective professional relationships
- Management of supplier corrective action system, investigation of supplier related problems and maintain supplier audit/questionnaire programme
- Providing wider ad-hoc departmental support as requested
Long term, as part of our commitment to continuously develop the successful candidate there will be the opportunity to take on the following duties:
- Assisting with new product introduction in line with compliance and quality practices
- Conducting internal audits
- Arranging and participating in customer quality audits
- Ensuring technical and quality agreements are in place with suppliers
- Supporting with CSV (Computer System Validation) activities as requested
Knowledge, experience, qualifications & skills required:
Essential:
- Ability to demonstrate good numeracy & literacy skills through qualification and professional experience
- Computer literate: Experienced and proficient in Microsoft Office platforms
- Excellent organisational skills and attention to detail
- Effective and clear communicator
- Ability to prioritise and manage deadlines
- Analytical with investigative skills
- Experienced with report writing
- Ability to build and maintain effective professional relationships with internal and external stakeholders
- Experience of auditing
- Willingness to learn & understand the pharmaceutical industry and the regulatory processes
- This is a predominantly office/site based role, however flexibility for very occasional travel may be required
- Ability to work flexibly to the needs of the business
Desirable:
- Experience within the pharmaceutical industry
- Science based University degree
- An understanding of Good Manufacturing Practice (GMP)
- Previous experience in a quality role and/or a trained Quality Auditor
- Knowledge of Commercial Product registration requirements
- Knowledge of ISO 9001 Quality Management Systems
Experience of working within Warehouse Operations
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.
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.
PCI Pharma Services
www.pciservices.com
Philadelphia, United States
Salim Haffar
$25 to $50 million (USD)
1001 to 5000 Employees
Company - Private
Health Care Products Manufacturing
