Seniority level
Mid-Senior levelEmployment type
Full-timeJob function
Quality AssuranceIndustries
Pharmaceutical Manufacturing-
IT Support Manager
3 weeks ago
Avanti Wooburn Green, United KingdomAvanti Recruitment is working with a leading nationwide integrated waste management business, that seeking a highly motivated and experienced IT Support Manager to join their team. In this role, you will be responsible for the successful delivery of allIT services, ensuring the c ...
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Vehicle Technician
1 week ago
The Recruitment Solution (London) Ltd Wooburn Green, United KingdomVehicle Technicians, · Are you looking for an opportunity to be part of a dealer group that can offer a great salary of £35,000 to £40,000 plus continuous support to help you achieve your career goals, ongoing training and fantastic company benefits? "Then Look No Further". · The ...
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Finance Assistant
3 weeks ago
Platinum Resourcing Wooburn Green, United KingdomThis is a 6 month temporary position, full time, hybrid working. · **Duties**: · - Managing supplier invoices · - Maintaining strong relationships with suppliers · - Matches of invoices in preparation for payments · - Managing the ledger and supplier statements · - Liaising with ...
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IT Technical Sales Apprenticeship
3 weeks ago
Intequal Wooburn Green, United Kingdom**Vacancy Overview**: · **Working Week**: · Monday - Thursday 9:00am to 5:30pm, Friday 8:00am to 4:00pm · **Weekly Wage**: · £17000 · **Detailed Job Description**: · Intequal, in partnership with the Microsoft Apprenticeship Programme, are offering this exciting opportunity to em ...
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Temporary Customer Services Associate
6 days ago
Trinity Resource Solutions Wooburn Green, United KingdomLooking for someone who can record and manage customer issues and defects. Experience with CRM systems basic training will be given. A strong admin background and an understanding of property terminology would be desirable along with some experience withdealing with customer serv ...
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Project Manager
2 weeks ago
Ethypharm Wooburn Green, United KingdomJob Description · Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · Our commitment is to improve patients' lives ...
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Project Manager
1 week ago
Ethypharm Wooburn Green, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · For a complete understanding of this opportunity, and what wil ...
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Project Manager
1 week ago
Ethypharm Wooburn Green, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · Our commitment is to improve patients' lives and make a posit ...
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Senior Manager/ Assistant Senior Manager
2 weeks ago
Signet Resources Wooburn Green, Buckinghamshire, United KingdomAre you a Senior Health & Safety expert within Social Housing or Property? We are looking for an Assistant Director for Health& Safety who has a firm understanding and experience from within the Social Housing or Property and understands the regulations and hazardous legislation ...
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QA Manager
1 week ago
Ethypharm Wooburn Green, United KingdomEthypharm is a European pharmaceutical laboratory whose mission is to improve patients' lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine. · The role of QA Manager & Qualified Person (3rd Party) is ...
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QA Manager
2 weeks ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomEthypharm is a European pharmaceutical laboratory whose mission is to improve patients' lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine. · Check out the role overview below If you are confident yo ...
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Project Manager
4 hours ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · Please ensure you read the below overview and requirements for ...
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Compliance Manager
2 weeks ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Ethypharm has 1,700 employees dedicated to its various pharmaceu ...
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Project Manager
1 week ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · For a complete understanding of this opportunity, and what wil ...
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Project Manager
1 week ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomDirect message the job poster from Ethypharm · Ethypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. · Our commitmen ...
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QA Manager
2 weeks ago
Ethypharm Wooburn Green, Buckinghamshire, United KingdomEthypharm is a European pharmaceutical laboratory whose mission is to improve patients' lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.The role of QA Manager & Qualified Person (3rd Party) is bas ...
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Regulatory Affairs Manager
2 weeks ago
Ethypharm Wooburn Green, United KingdomEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. Our commitment is to improve patients' lives and make a positive ...
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Product Manager
3 weeks ago
CPI Selection Wooburn Green, United Kingdom Full timePosition: Product Manager - Engine Division · Location: Buckinghamshire, UK · Salary: £70K-£75K · Our client is a World Leader in the Motor Manufacturing industry and supplier of top-tier commercial and residential engines, catering primarily to the Turfcare and garden equipment ...
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Product Manager
3 weeks ago
CPI Selection Wooburn Green, United Kingdom Full timePosition: Product Manager - Engine Division · Location: Buckinghamshire, UK · Salary: £70K-£75K · Our client is a World Leader in the Motor Manufacturing industry and supplier of top-tier commercial and residential engines, catering primarily to the Turfcare and garden equipment ...
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Technical Production Manager
1 week ago
Royall Appointments Wooburn Green, United Kingdom Full timeTECHICAL PRODUCTION MANAGER · Bucks, £50k - flex hybrid working. · Who for? · A truly caring, compassionate and credible, leading brand experience agency who design and deliver remarkable live events, exhibits and branded environments, plus virtual experiences and experiential ma ...
QA Manager - Wooburn Green, Buckinghamshire, United Kingdom - Ethypharm
Description
QA Manager & Lead Qualified Person - 3rd Party
1 week ago Be among the first 25 applicants
Ethypharm is a European pharmaceutical laboratory whose mission is to improve patients' lives by providing essential drugs focusing on hospital care, central nervous system (severe pain, addiction) and internal medicine.
The role of QA Manager & Qualified Person (3rd Party) is based out of our commercial site in High Wycombe reporting to our External Operations Quality Director.
In this role you will be responsible for the management of all Quality aspects involving our CMO business, ensuring compliance with the 3rd party QMS. You will resolve day-to-day issues to maintain the quality of supply as well as providing technical input into projects such as product transfers. You will be the principle Qualified Person regarding the QP certification activities for products manufactured at multiple sites. You will manage a small team comprising 3 Quality Assurance Officers and a Quality Support Manager, working closely with supply chain, regulatory, medical info and pharmacovigilance teams.
Main responsibilities:
·· Management of the 3rd party Quality team, ensuring appropriate training plans to ensure their personal development and growth
· To ensure that batch reviews are completed by the team within the required timeframe for QP release
· To be the point of contact for supply chain and other QPs with respect to batch release and associated issues
· Liaise with relevant parties to communicate any issues with product supply and assist with the resolution as required
· Ensure compliance with the required timelines for investigations, complaints, change controls, PQRs, CAPAs, document updates, temperature excursion assessments & artwork updates impacting the 3rd party team
· To assist with the review of PQRs, temperature excursions, customer complaints, deviations, change controls and other GMP activities associated with 3rd party supply
· To participate in, or lead audits of CMOs or Distribution Partners in accordance with the agreed schedule
About you
· Excellent time management, communications, decision-making, and organisation skills
· Positive mindset, ethical yet pragmatic
· Team player, able to work with remote colleagues and diverse cultures
Skills/Education
· Eligible as a Qualified Person as defined in Human Medicines Regulations 2012 (as amended)
· Good understanding and experience of Pharmaceutical Quality Management Systems in line
with ICH Q10 requirements
· Understanding of Good Manufacturing Practices
· Understanding of ICH Q1 requirements for stability testing
At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business. Visit our website at to learn more about Ethypharm.
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