Quality & Compliance Pharmacist
Aguettant Ltd, based in Bristol, is the UK subsidiary of a French family owned company, Laboratoire Aguettant, operating in the field of essential, emergency medicines. Laboratoire Aguettant are committed to driving improvements in the safety and quality of emergency care and are making a positive difference by designing products that enable healthcare professionals to deliver better, faster and cost-effective patient care. Aguettant Ltd, as the No1 affiliate, has experienced significant growth over the last couple of years, and it has become clear that there is a need for a high calibre individual with industry/pharmacy experience to join our team and build upon our success.
The Quality & Compliance pharmacist will act as an ambassador for the company, providing high standards of service and care to our customers. A key function of the role will be to propose and define ways to improve working procedures, as well as taking full responsibility for our Quality Management System, GDP, Pharmacovigilance, Compliance, Training and Regulatory. The company will support PMCPA & RP related training/ongoing development.
This is a real “all-rounder” role that will tangibly impact the ongoing success of the business. The company enjoys a great working culture which is evidenced in the tenure and stability of our staff and indeed our track record of internal succession planning. We boast a strong pipeline of new product development which will enable this position to expand even further.
We are looking for a qualified pharmacist who has gained experience in the healthcare and pharmaceutical industry – You may be working in a “narrower” role at present and seek an opportunity to broaden your responsibility. You will be able to achieve high standards with meticulous attention to detail and be a confident communicator internally and externally. We are happy to consider part-time or flexible working patterns.
The Quality & Compliance Pharmacist is responsible for the following key areas of operations at Aguettant Ltd.
Act as Responsible Person for Aguettant Ltd as defined by MHRA.
Ensure that conditions of the wholesaler dealers’ license are met and operations in the UK and Republic of Ireland are carried out within GDP guidelines.
Responsible for the local Quality Management System.
Establish and maintain QMS to comply with UK & IE regulations, corporate and local requirements.
Ensure consistent implementation of QMS across the company and promote continuous improvement culture.
Act as Local Safety Officer for Aguettant Ltd.
Accountable for ensuring that the pharmacovigilance system in place within the local organisation is adequate, efficient and compliant with regulatory and corporate requirements.
Ensure compliance with local and Corporate SOPs, GDP, GPvP, PMCPA guidelines and pharmaceutical legislations.
Responsible for the management of Pharmacovigilance spontaneous reports, complaints and scientific information
Responsible for developing and conducting training programs in matters relating to PV, GDP and PMCPA compliance.
Regulatory review and approval of promotional material, SPC & packaging mock up for UK & IE products.
For more information, or to apply for the role, please contact firstname.lastname@example.org
Salary (£): On application
Benefits: Attractive performance related benefits available
Pharmaceutical Solutions Ltd is an independent consultancy that provides a wide range of QP, QA, GMP and regulatory services to the pharmaceutical and veterinary industries including importation and certification.
Representatives of the company are qualified persons (QPs) and are able to provide general support and/or batch certification for a range of products for investigational (clinical trials) or commercial use, including oral, sterile and topical dosage forms as well as medical gases.
The company also offers auditing services, on-site or remote quality/technical support and quality system development.
The company has a full-time opportunity for a QP to join the team, based in the North-West of England, near Chester. The position is available immediately or after the end of a required notice period.
The successful candidate will work with clients based in the UK, Europe and across the world. The office near Chester is the normal place of work, although travel to sites on behalf of clients, including sites abroad, is a regular occurrence.
The focus of the role will be to provide a portfolio of clients with GMP site support, batch certification and auditing of supply chains.
The candidate must be eligible to act as a Qualified Person for human or human and veterinary medicinal products (as defined in EU Directives 2001/83/EC, 2001/20/EC and 2001/82/EC). The candidate should preferably have three years’ experience working as a QP, although newly qualified candidates with at least five years’ experience working in a GMP quality role are welcome to apply. Knowledge and experience of sterile products and/or investigational medical products (clinical trials) would be advantageous.
For more information, or to apply for the role, please contact email@example.com. If applying, please send a CV, along with a covering letter detailing how your experience and abilities make you suitable for the job.
Alliance Medical Radiopharmacy (AMR) produces radiopharmaceuticals for use in Positron Emission Tomography (PET). Our aim is to provide a high quality reliable supply of radiopharmaceuticals to PET imaging centres across the UK.
We have some exciting opportunities for Qualified Person’s to join our sites at Preston, Guildford and Sutton. This is on either a permanent or contract basis and we will consider applications from both. We require individuals who have had experience and responsibility for Quality Management Systems, to ensure compliance with the requirements of Good Manufacturing Practice.
Key responsibilities are:
- To review and evaluate batch records and authorise batch disposition.
- To manage the site QMS, monitor compliance with GMP and drive quality improvements.
- To ensure that testing is carried out according to AMR analytical control procedures and EU Pharmacopoeia specifications.
- To review and approve deviations and laboratory investigations in compliance with GMP and AMR procedures.
- To investigate and respond to complaints.
- To co-ordinate the AMR recall procedure.
- To ensure appropriate analytical method validation/verification is carried out for all analytical test methods.
- To support site validation activities ensuring that regulatory requirements are met.
- To review and approve change controls.
- To co-ordinate AMR internal and external auditing programmes.
- To monitor performance of suppliers, contract laboratories and contract manufacturers (where applicable).
- Responsible for following agreed safety procedures to ensure safety of self and others.
- To provide QA advice / support as necessary.
- To review GMP and GLP training plans prepared for AMR personnel and contracted service personnel (maintenance and cleaning) as appropriate.
- To participate in training and assessment activities related to the position of QP.
The successful candidate will be qualified to degree level (as a minimum) in a relevant scientific discipline.
The candidate must be eligible to act as a Qualified Person for medicinal products (as defined in EU Directive 2001/83/EC) and have been named on a UK MIA. The ideal candidate should have at least 5 years’ experience in a GMP QA role within the pharmaceutical industry and experience of managing quality systems.
Experience of working with sterile dosage forms would be advantageous for this role. Previous line management experience would also be beneficial.
The hours of work for these roles are 40 per week.
To apply for these positions and view our other Radiopharmacy vacancies please visit http://inside.alliancemedical.co.uk/
Alliance Medical operates a robust pre-employment screening process for all roles which includes the following checks:
Identity, Right to work in the UK, Professional registration and qualifications, Employment history and references (for the previous 5 years), Criminal record and barring (Standard or Enhanced DBS check) and Occupational health assessments. All offers of employment are subject to satisfactory completion of these checks.
Alliance Medical is committed to ensuring that recruitment and selection practices are conducted in a manner that promotes equality of opportunity.
At Alliance Medical, our core values of Collaboration, Excellence, Efficiency and Learning underpin all that we do. If you become a member of our team, you will join us in living these values every day, to ensure the best care for our patients.