Basildon, Essex

Quality Systems Manager

Basildon, Essex
Salary: Competitive + Benefits + Bonus

If you are a highly proactive and collaborative professional with technical expertise in developing and improving quality systems, then we want to hear from you!

Join us to help improve peoples’ lives and make healthcare better for everyone!

Why Pharmanovia?

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 140 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 250 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.E., India, Singapore, Italy, and South Korea.

We are an agile and imaginative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the role:

This is a key role with responsibility for the design, implementation and maintenance of our Quality System (PQS). You will be our go to person for queries and lead our self-inspection program based on risk assessment principles, ensuring this program is communicated to internal customers to meet the requirements of GMP.

  • Responsible for the compilation, organization, follow up and hosting of the company Management review process highlighting of trends and areas of noncompliance and improvements initiatives/actions identified during this review process.
  • Responsible for the continuous improvement and inspection readiness processes
  • Providing first hand support in the preparation and hosting of external inspections.
  • In conjunction with Line manager and/or Pharmanovia affiliates you’ll be responsible for the preparation of BOH responses and the follow up of actions ensuring timely deliverables are obtained.
  • Leading internal and external third-party inspections
  • Providing direction and guidance to the QMS/compliance specialist team. Responsible for goal setting, review and appraisal of quality specialists.
  • A key deliverable of the role will be to ensure that the quality system meets the regulatory and operational needs of Pharmanovia.
  • Effective management of all the PQS activities, including setting & monitoring key performance indicators (KPIs) and to present these KPIs at the Quality review Meeting
  • Ensure training requirements are specified for training of Pharmanovia staff 
  • Lead Change controls as required
  • Perform and/or delegate internal and external audits
  • Ensure self-inspection schedule is planned/managed and individual internal audits are assigned, planned, executed and closed accordingly
  • Ensure PQRs are completed in line with the planned schedule
  • Lead inspection readiness activities and actively support customer and regulatory audits
  • Chairing Change control, CAPA, Risk management, Recall committee meetings, as necessary
  • Ensure documentation administration and control
  • Ensure External Stability is tracked to maintain compliance
  • Ensure CSV validation responsibilities are maintained in line with Eudralex Annex 11 requirements
  • Subject matter expert for CSV to support customer and regulatory audits Act as the SAP and eQMS Quality system administrator and ensure the compliance and governance activities are undertaken for SAP
  • Document System Quality risk associated with the SAP project.
  • Ensure CSV validation responsibilities are maintained in line with Eudralex Annex 11 requirements
  • Ensure that all work is performed in compliance with GMP, Health & Safety and internal standards and policies

About you:

You will have experience in the management of computer system validation as well as root cause analysis and CAPA, continuous improvement, people leadership, and auditing.

  • Graduate in Pharmaceutical Science or equivalent
  • Postgraduate Degree or Diploma in Pharmaceutical Science or equivalent would be considered an advantage
  • Proven experience of CSV
  • Previous of facilitating Investigation and Root Cause Analysis
  • Previous experience of working in a pharmaceutical company in a role with significant responsibility.
  • Previous experience of routinely preparing and approving validation Documentation
  • Good working knowledge of Current Good Manufacturing Practice, Standard Operating
  • Procedures, EU GMDP guidelines, regulations and ICH Guidelines  
  • Training & supervisory skills with ability to influence, instruct & listen
  • Good organisation & time management skills
  • Positive attitude and flexible approach to work
  • Ability to forge sound working relationships with others

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.

Apply now and become part of our team

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