Quality Specialist
6 months ago
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
We are looking for a someone with a critical decision-making, as the job holder will review and approve deviations and change controls, as well as addresses non-compliance issues, and initiates quality improvements.
Main responsibilities- To provide technical Quality support to the Operational departments for new and ongoing projects.- Play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines which assists with regulatory compliance.- To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.- To conduct performance audits and follow up on actions within site business units.- Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.- Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)- QA approval of Item Masters.- Batch record compilation and regulatory checks.- Interpret PQR data.- Review and approve Deviations and Change Controls as needed.- To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP’s), and to initiate and promote quality improvements to prevent re-occurrence.-
- To assist with GMP training within the department and cross site.
**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:
- 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.
LI-AT1
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._
-
Senior Quality Specialist
7 months ago
Tredegar, United Kingdom PCI Pharma Services Full timeLife 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. - To ensure the effective management of the...
-
Quality Technician
2 days ago
Tredegar, United Kingdom Rise Technical Recruitment Limited Full timeQuality Technician Workshop Based (Abergavenny, Merthyr Tydfil, Tredegar Commutable) £27,000 - £29,000 + Career development & Progression + Great work life balance (37 hours Monday to Friday, early finish Friday) + Benefits Are you a Quality technician or Coordinator looking to join a bespoke, blue chip business as they continue to thrive and expand -...
-
Toolmaker Specialist
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Rise Technical Recruitment Full timeWe are seeking a skilled Toolmaker Specialist to join our team. As a Toolmaker Specialist, you will be responsible for designing and developing tools for the production of plastic parts. This is a fantastic opportunity to showcase your skillset and work with a bespoke engineering specialist.The ideal candidate will have a strong background in plastics and...
-
Manufacturing Specialist
1 month ago
Tredegar, Blaenau Gwent, United Kingdom PCI TRGR Penn Pharmaceutical Services Ltd Full timeAbout the RoleWe are seeking a skilled Manufacturing Specialist to join our team at PCI TRGR Penn Pharmaceutical Services Ltd.As a key member of our production team, you will be responsible for dispensing raw materials, preparing bulk liquid solutions and semi-solid masses, and operating packaging equipment.The ideal candidate will have experience in...
-
Mechanical Manufacturing Specialist
23 hours ago
Tredegar, Blaenau Gwent, United Kingdom Vibe Recruit Limited Full timeWe are seeking a highly skilled Mechanical Manufacturing Specialist to join our team in Tredegar. As a Mechanical Manufacturing Specialist, you will be responsible for the service and maintenance of all injection moulding and press tools on site.The salary for this role is £35,000 - £45,000 depending on experience. You will work Monday to Friday with half...
-
Industrial Electrical Specialist
4 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Gap Personnel - Cardiff Full time**About the Role:**As an Industrial Electrical Specialist, you will be responsible for performing electrical installations, repairs and maintenance across various plant locations. You will work closely with our team to ensure that all projects meet quality and safety standards.**Responsibilities:**Electrical installation and repair workMaintenance and...
-
Occupational Therapy Specialist
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom R S D TECHNOLOGY LIMITED Full timeJob OpportunityWe are seeking a skilled Occupational Therapy Specialist to support young adults with disabilities in the community.This role involves delivering high-quality assessments, interventions, and ongoing care within home, educational, and community settings. The successful candidate will work closely with multidisciplinary teams and external...
-
Pharmaceutical Network Specialist
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom PCI TRGR Penn Pharmaceutical Services Ltd Full timeAt PCI Pharma Services, we're dedicated to delivering quality and operational excellence. As a Pharmaceutical Network Specialist, you'll play a crucial role in building our global network to pioneer life-changing therapies.About the RoleThis is an exciting opportunity to join our team as a key member in shaping the future of PCI. You'll be responsible...
-
Qualified Primary Teacher Specialist
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Vetro Recruitment Full timeWe are looking for an accomplished Qualified Primary Teacher Specialist to join our team of educators working across Primary schools in Wales. As a Registered Agency Worker with Vetro Recruitment, you will benefit from flexible working hours, weekly pay without payroll charges, and the opportunity to work in diverse educational settings.Competitive Hourly...
-
Nursery and Primary Education Specialist
1 month ago
Tredegar, United Kingdom Prospero Teaching Full timeJob Description:">We are looking for a highly motivated Nursery and Primary Education Specialist to join our team. As a Nursery Nurse, you will be responsible for delivering high-quality educational programs to children aged 3-5 years old. Key Responsibilities:">">Develop and implement effective lesson plans in collaboration with colleagues.">Maintain a safe...
-
Occupational Therapy Specialist
1 week ago
Tredegar, United Kingdom R S D TECHNOLOGY LIMITED Full timeRole OverviewWe are seeking a skilled Senior Occupational Therapist to support children and young adults (0-25) with disabilities. This role involves delivering high-quality assessments, interventions, and ongoing care within home, educational, and community settings.Key ResponsibilitiesCaseload Management: Prioritize and manage occupational therapy...
-
Production Fabricator
1 month ago
Tredegar, United Kingdom Gap Personnel - Cardiff Full timeWe are seeking an experienced Fabrication Specialist to join our team at Gap Personnel - Cardiff.As a skilled Welding Technician, you will be responsible for competently carrying out TIG, MIG and MMA welding on all metals, including mild steel and stainless steel. You will work accurately in a fast-paced environment and maintain high standards of quality and...
-
Senior Occupational Therapist
1 day ago
Tredegar, Blaenau Gwent, United Kingdom R S D TECHNOLOGY LIMITED Full timeJob OverviewR S D TECHNOLOGY LIMITED seeks a highly skilled Senior Occupational Therapist to provide high-quality assessments, interventions, and ongoing care for children and young adults (0-25) with disabilities in home, educational, and community settings.Key Responsibilities:Caseload Management: Prioritize and manage occupational therapy referrals...
-
Therapy Lead in Pediatric Care
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom R S D TECHNOLOGY LIMITED Full timePediatric Therapy SpecialistR S D TECHNOLOGY LIMITED is seeking an experienced Senior Occupational Therapist to join its team as a Pediatric Therapy Specialist.The successful candidate will be responsible for providing high-quality occupational therapy services to children and young adults (0-25) with disabilities in home, educational, and community...
-
Bespoke Project Engineer Position
2 weeks ago
Tredegar, United Kingdom Rise Technical Recruitment Full timeAn exciting opportunity has arisen for a Process/Project Engineer with experience in plastics or injection moulding to join a leading specialist in the automotive sector. Our client is looking for a highly skilled and ambitious engineer to work as part of a close-knit team on bespoke projects from concept to completion.About the CompanyOur client is an...
-
Bespoke Process Development Expert
4 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Rise Technical Recruitment Limited Full timeAre you an experienced Toolmaker or Engineer looking for a new challenge? We are seeking a talented individual to join our team as a Plastics and Injection Moulding specialist.This role involves working closely with clients to understand their needs and deliver high-quality solutions. Key responsibilities include:Developing bespoke solutions for...
-
Occupational Therapist Professional
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom R S D TECHNOLOGY LIMITED Full timeWe are seeking a skilled Senior Occupational Therapist to support children and young adults with disabilities. The successful candidate will be responsible for delivering high-quality assessments, interventions, and ongoing care within home, educational, and community settings.The estimated salary for this role is £50,000 - £60,000 per annum.Key...
-
Injection Moulding Engineer
2 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Rise Technical Recruitment Full timeWe are looking for an experienced Injection Moulding Engineer to join our team. In this role, you will be responsible for designing and developing tools for the production of plastic parts, and collaborating with cross-functional teams to ensure smooth project delivery.This is a fantastic opportunity to develop your skills and work with a bespoke engineering...
-
Customer Assistant
7 months ago
Tredegar, United Kingdom Lidl Full timeSummary Starting from £11.00 per hour - This isn’t stacking shelves. This is feeding families. As a Customer Assistant at Lidl, no shift is the same and you get out what you put in. Starting at 5am some days to set up the store bakery for the day or finishing at 11pm on others to close the store and ensure the store is ready for another day of...
-
Personal Support Specialist
3 weeks ago
Tredegar, Blaenau Gwent, United Kingdom Support Ethics Full timeAbout Our ServicesWe provide top-quality support services to individuals with diverse needs, helping them achieve their goals and live fulfilling lives.Our team of highly motivated and compassionate professionals work together to deliver exceptional care and support.Role OverviewIn this rewarding role, you will play a vital part in supporting individuals and...