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Process Validation Specialist

1 month 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.

**Job Description**:
We are now looking for a Process Validation Specialist to join our team.

Main purpose of role:
To ensure the validated state of all cGMP manufacturing and packaging processes at PCI Tredegar.

The job holder is responsible for adhering to PCI standard operating procedures (SOPs) Health, Safety and Environmental Rules, General Data Protection Regulations (GDPR), Good manufacturing Practices (GMP) and other regulatory guidelines.

Main responsibilities:
- To ensure the Site Validation Master Plan is adhered to and maintained in accordance with the required risk based, lifecycle approach.-
- To ensure timely generation of documentation for Manufacturing and primary packaging- Process Validation.- Liaise with internal departments to progress Process Validation studies.- Take part in Risk Assessments to determine the validation approach for validation projects.- To generate, execute and peer review appropriate documentation to enable lifecycle validation of: Manufacturing and Primary packaging processes: Process Validation Protocol, Process Validation Report, Continued Process Verification Protocol, Continued Process Verification Report, Third Party validation documentation and studies, as appropriate.- Support execution of Process Validation studies.- Use of a Continuous Improvement ethos to standardise and optimise Process Validation at PCI.- Sustain a working environment that promotes the PCI pharma services values and behaviours.- Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS and cGMP standards, procedures and systems.- Be a strong team player with open communication style with the ability to direct others and deliver clear instruction, including internal personnel, suppliers and contractors.

Work Experience:
Essential- Experience in manufacturing and packaging of pharmaceuticals or medical devices, ideally pharmaceutical manufacturing of oral solid dose, oral liquid dose, topical ointments and creams.- Proficient user of software packages including MS Excel, Word, Powerpoint and Visio, together with a high level of computer literacy.

Desirable- Proficient in the use of MS Project and Statistical software (JMP/Minitab). People Management experience.

Qualifications:
EssentialDesirable- PCI management 101,- Lean Six Sigma yellow belt qualified

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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