Sector: Life Sciences
Consultant: Stewart McGrath
Salary: £85000 - £100000
Job Status: Permanent / Full Time
Position is equivalent to QA Operations Manager / QA Compliance Manager and reports to the site Quality Director.
- Depending on the size/complexity of the site the incumbent may or may not have man management responsibilities.
- Incumbent will need to operate within a matrix management system to deliver their key responsibilities
- Execute Qualified Person (QP) responsibilities, duties, batch certification and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU and Eudralex Volume 4, Annex 16. If the product is to be released to the US market, all appropriate cGMP’s requirements as defined is US. “CFRs” and other relevant regulations should be complied with.
- Ensure that products are manufactured in accordance with GMP, site procedures and applicable regulatory requirements.
- Maintain a thorough and up to date understanding of international regulatory guidance, corporate and client requirements pertinent to the site, and to ensure that all work within the site complies with these and with site procedures.
- Take actions necessary to maintain and extend their technical and professional competence and to ensure that they have a thorough understanding of any new product or process prior to conducting any QP batch certification and disposition.
- Undertake regular audits, self-inspections and spot checks.
- Undertake and support investigations, root cause analysis and review & approve Major/Critical deviation, Complaints and any change proposals with process/product impact.
- Undertake and support the QMR process.
- Undertake and support the implementation of Operation Excellence by encouraging peers and stakeholders to identify, lead and implement improvements.
- Act as change agents by gaining support for and driving sustainable improvements to ways of work
- Proactively ensure continuous improvement of the QMS and that it is inspection ready and maintained in a state of control
- Proactively drive and react to system trending (e.g. deviations, complaints and environmental management) to ensure ongoing quality performance and improvements.
- Establish and maintain effective communication with clients to match internal and external client expectations
- Backup for other QP’s on site and Deputise for the sites Quality Director
- Understand and ensure implementation of emergency procedures and safe systems of work.
- Ensure compliance with environment, health and safety rules, signage and instructions at all times.
- Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
- Minimum Degree in Chemistry, Pharmacy or Microbiology
- Minimum 3 years’ experience acting and executing ‘Qualified Person’ responsibilities and duties as defined in 2001/83/EC and 2001/82/EC (as amended)
- Substantial experience working in a pharmaceutical quality function within a sterile manufacturing site, experience with Cephalosporins/Penicillin is preferable
- Up to date knowledge of the principles and guidelines for GMP as set out in: UK “Orange Guide”, EU “Eudralex Volume 4”, U.S. “CFRs” and other relevant regulations.
- Excellent scientific and technical knowledge
- Pre-requisite for this job is that the candidate is not on the “FDA DEBARMENT LIST”
- Capable of working to deadlines and prioritize multiple tasks
- Excellent written and verbal communication skills to internal and external stakeholders
- Flexibility to meet changing needs and priorities of the business
- Pragmatic, well organised with logical and methodical approach to work
- Leadership experience and the have the strength of character to guide cross-functional teams of professionals
You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.
Are you ready for the challenge? If so, we look forward to hearing from you.
What else can you expect from Seven?
– Specialist Consultant allocated to you with all the expertise you require.
– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.
– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.
– £250 Referral Bonus for every person you successfully refer to Seven.
For more information please contact Stewart McGrath in the Life Sciences team on 0203 8877365 or email to [email protected] anytime.