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Validation Specialist

2 months ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time
Main Purpose of Role:

To ensure the qualified state of all cGMP facilities, utilities, manufacturing, packaging, and analytical equipment at PCI Pharma Services is maintained in accordance with the required risk-based, lifecycle approach.

Main Responsibilities:
  1. To participate in Risk Assessments to determine the validation approach for Facilities, Utilities, and Equipment, ensuring those which have a GxP impact are appropriately qualified.
  2. To ensure the documentation utilized for Facilities, Utilities, and Equipment Qualification has been generated in compliance with Statutory, Regulatory, Client, and Company expectations.
  3. To work closely with Project Management Teams in Pharmaceutical Development, Technical Affairs, Operations (inclusive of Engineering), Supply Chain, and Clients to ensure projects are progressed in a timely manner.
  4. To support the execution of Qualification studies, ensuring: Standard Operating Procedures (SOPs) and Work Instructions (WIs) associated with the Qualification study are available and adequate for their intended use.
  5. All equipment used during a Qualification study is appropriately calibrated to a recognizable international/national standard.
  6. Any deviation to the acceptance criteria associated with a qualification study is adequately documented and an action plan agreed as required.
  7. All key findings are adequately reported, concluding whether the Qualification study has been successful and whether the system is fit for routine GxP use.
  8. To be a Subject Matter Expert in one Validation discipline, and able to represent that expertise at client-facing meetings and at audit.
  9. To ensure a Continuous Improvement ethos is upheld, periodically reviewing Standard Operating Procedures (SOPs), Work Instructions (WIs), Templates, and Forms with the purpose of standardizing and optimizing the Qualification approach, whilst still maintaining Regulatory compliance.
Requirements:
  1. Experience in Manufacture and Packaging of Pharmaceuticals or Medical Devices, ideally Contract Pharmaceutical manufacturing of Oral Solid Dose, Oral Liquid Dose, Topical Ointments, and Creams.
  2. Extensive working experience of Validation Disciplines, preferably Facilities, Utilities, and Equipment Qualification.
  3. Working knowledge of Good Manufacturing Practices, Eudralex Volume 4 specifically Annex 15 and ICH, particularly ICH Q9.
  4. Proficient user of software packages including MS Excel, Word, PowerPoint, and Visio, together with a high level of computer literacy.
  5. Able to statistically analyze data to determine process capability.
  6. 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.
  7. Proficient in the use of MS Project and Statistical Software.
  8. People management experience (desirable).
  9. Educated to BTEC HND or degree level in a Technical, Engineering, or Science subject or a minimum of five years previous experience working in a similar technical role.
  10. Face-to-face communication.
  11. Good listening skills.
  12. Attention to detail.
Benefits:

At PCI Pharma Services, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:

  1. Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
  2. Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
  3. Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
  4. Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
  5. Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you.
  6. Staff Engagement: We value your dedication with recognition schemes and long-service awards.
  7. Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
  8. On-Site Subsidized Canteen.
  9. Cycle to Work Scheme.
  10. Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.

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Let's build the bridge between life-changing therapies and patients.

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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