- The job holder will be required to understand and interpret regulations of MHRA/EU/FDA. Pharmaceutical products manufactured by PCI are manufactured under the most stringent regulatory and GMP requirements and must be produced to the highest ethical standards.
- Responsible for the interpretation of cGMPs for all manufacturing and packaging activities including development, clinical, commercial and unlicensed products.
- The job holder makes a number of quality decisions which directly affect the release of materials. Whilst operating under such pressure to meet business deadlines, the job holder must evaluate complex data and in the absence of prescribed rules, assist in making professional judgements which could have considerable impact on the compliance and profitability of the business.
- The scope of the role covers all manufacturing and packaging areas across site ().
- The job holder may have direct people management responsibilities for team members and ensuring that all KPIs, targets and any other deadlines are met individually and by the team.
- To review non-compliance identified by audit, deviations and complaints, and use technical judgement to make the appropriate product quality decisions (in association with Quality management), and to initiate and promote quality improvements to prevent re-occurrence including attendance at daily triage meeting.
- To ensure the review and approval of all documentation relating to manufacturing to support their continued processes to meet the business needs.
- To conduct internal performance audits and follow up actions within site business units.
- To play a lead role in the efficient review and approval of batch documentation to ensure deadlines are met and where required, effective and efficient correction of QP review comments.
- To lead and drive online triage process.
- Complete Operational GEMBA walks and drive improvements within the Quality and Operations departments.
- To play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve experimental and validation reports / protocols where appropriate.
- To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.
- To provide statistical trending reports on quality key performance indicators and to initiate corrective and preventative actions based on this data. To generate a monthly report on the key activities and key performance indicators for the area.
- To deputise for Quality Operations Manager where required.
- To manage team performance and absence standards, including coaching, counselling and disciplinary measures as required. To conduct performance appraisal and to set targets and objectives for individual members of the group.
- To manage and process all HR and departmental documentation for the team members including attendance, overtime, training, sickness related documents, absence requests, annual leave and staff appraisals including 1:1s, probationary reviews and PMRs.
- To supervise the work of subordinate roles in the assigned business unit or operational section. Identify self-development needs for future performance and development needs for team members/direct reports.
- Ensure compliance with company policies and procedures and internal and external Health and Safety and Environmental standards for themselves and team members.
- Employer Pension: Secure your future with our employer pension scheme (above statutory pension).
- Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.
- Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.
- Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.
- Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you
- Staff Engagement: We value your dedication with recognition schemes and long-service awards.
- 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.
- On-Site Subsidized Canteen.
- Cycle to Work Scheme.
- Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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QA Specialist - Tredegar, United Kingdom - PCI Pharma Services
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.
The role:
The successful candidate will be responsible for assisting the Quality management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with current Good Manufacturing Practise standards and in accordance with company policies to meet business requirements. The candidate will work primarily with the manufacturing and packaging departments to provide guidance and expertise in the resolution of quality issues. We are expecting a pro-active candidate in influencing business unit colleagues up to director level in circumstances where conflicts arise. The GMP elements of Quality Assurance are essentially "on plant" activities however there may be a need to discuss issues/interface with clients.
This is a full-time and on-site based role. There is a two shift rotation Monday to Friday.
Main tasks:
Skills and Requirements
Benefits
At PCI, 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:
Join us and be part of building the bridge between life changing therapies and patients.
