![Ethypharm](https://media.trabajo.org/img/noimg.jpg)
QA Manager
2 weeks ago
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
· Auditing experience
· 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.
-
QA Manager
2 weeks ago
Wooburn, Buckinghamshire, United Kingdom Ethypharm Full timeJob DescriptionEthypharm 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...
-
QA Manager
2 weeks ago
Wooburn Green, United Kingdom Ethypharm Full timeEthypharm 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...
-
QA Manager
2 weeks ago
Wooburn Green, United Kingdom Ethypharm Full timeEthypharm 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...
-
QA Manager
2 weeks ago
Wooburn Green, United Kingdom Ethypharm Full timeEthypharm 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...
-
QA Manager
2 weeks ago
Wooburn Green, United Kingdom Ethypharm Full timeEthypharm 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.If your skills, experience, and qualifications match those in this job overview, do not delay your application.The role of QA Manager &...
-
QA Manager
2 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm 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...
-
QA Manager
2 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm 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...
-
QA Batch Release Officer
2 weeks ago
Bethnal Green, United Kingdom CY Partners Full timeLocation: Greater London Contract: Permanent Salary: up to £28,000 + shift allowance Shift: 7am - 3pm & 11am – 7pmDo you have a keen eye for detail and a passion for quality?Are you looking for a challenging and rewarding role in the pharmaceutical industry?Our client, a leader in delivering high quality, processed biological materials is...
-
Quality Assurance Administrator
2 days ago
Wooburn Green, United Kingdom Uxbridge Employment Agency Full timeQuality Assurance Administrator Salary: £24,000 to £35,000 (depending on level of experience) Based: Bourne End, must be a driver due to location. Are you passionate about maintaining high-quality standards and ensuring compliance with industry regulations? Join a dynamic team as a Quality Assurance Administrator, where you will play a crucial role in...
-
Quality Assurance Administrator
2 weeks ago
Wooburn Green, United Kingdom Reed Full timeQuality Assurance Administrator Salary: £24k - £35k (DOE)Location: Bourne EndJob Type: Full-time We are seeking a dedicated Quality Assurance Administrator to oversee and maintain our company’s quality management system. This role is crucial in ensuring that our products and services meet both internal and external legal requirements and standards set ...
-
IT Support Technician Apprentice
4 weeks ago
Lyme Green Business Park, United Kingdom QA Ltd Full time**Employer description:** The Company [Blaze Networks] are a security-focused Managed Services Provider and ISP, delivering network communications and IT services to businesses across the UK. We are fundamentally a customer and service-focused organisation, dedicated to ensuring our customers’ networks and IT systems are highly dependable, secure & cost...
-
Lead Quality Inspector
2 weeks ago
Wooburn Green, United Kingdom Oxon Park Ltd Full timeOxon Park is currently looking for a Lead Quality Inspector to join a subcontract precision engineering company in Wooburn Green, High Wycombe.Our client holds UKAS approval to ISO 9001 and specializes in high-precision CNC machining of a diverse range of components, from intricate to simpler parts.They continually invest in cutting-edge machining...
-
Quality Assurance Manager and Qualified Person
2 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm 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...
-
Quality Assurance Manager and Qualified Person
2 weeks ago
Wooburn Green, Buckinghamshire, United Kingdom Ethypharm Full timeEthypharm 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...
-
IT Support Technician Apprentice
2 weeks ago
Lyme Green Business Park, United Kingdom QA Ltd Full timeEmployer description:The Company [Blaze Networks] are a security-focused Managed Services Provider and ISP, delivering network communications and IT services to businesses across the UK.We are fundamentally a customer and service-focused organisation, dedicated to ensuring our customers' networks and IT systems are highly dependable, secure & cost...
-
IT Projects and Network Engineer Apprentice
2 weeks ago
Lyme Green Business Park, United Kingdom QA Ltd Full timeEmployer description:The Company [Blaze Networks] are a security-focused Managed Services Provider and ISP, delivering network communications and IT services to businesses across the UK.They are fundamentally a customer and service-focused organisation, dedicated to ensuring their customers' networks and IT systems are highly dependable, secure & cost...
-
QA Engineer
1 month ago
Turgis Green, United Kingdom SNCloudSolutions LLC Full timeHandson experience with C#, .Net, Selenium test framework, Specflow.Understand, suggest and implement the different design patterns to enhancePostmanJira XRayTeamcityJMeter/Blazemeter/NeoloadCreation of test dashboardsRelease managementFunctional testing
-
Children's Residential Home Deputy Manaer
4 weeks ago
Woodford Green, United Kingdom Woodford Full time**Job description Children’s Residential Deputy Manager** We are looking for a deputy manager or an experienced senior who is tired of the system the way it is and wants to work for an organisation that is prepared to do things differently, to support its staff fully through training and therapeutic supervision for you as well as your staff team, if this...
-
Site Engineer
4 weeks ago
Wood Green, United Kingdom RTL Group Ltd Full timeMy client is a leading groundworks and RC Frame sub-contractor who cover UK Wide. They are looking to on-board a site engineer to manage the engineering of a new contract that they have won in North London. The scope of works you will be required to manage includes setting out Groundworks, Drainage & RC Frames. Site engineer responsibilities: * Site set...
-
Site Engineer
3 weeks ago
Wood Green, United Kingdom RTL Group Ltd Full timeMy client is a leading groundworks and RC Frame sub-contractor who cover UK Wide. They are looking to on-board a site engineer to manage the engineering of a new contract that they have won in North London. The scope of works you will be required to manage includes setting out Groundworks, Drainage & RC Frames.Site engineer responsibilities: * Site set up...