Basildon, Essex

Quality Assurance Specialist – QMS

Basildon, Essex

Salary: Competitive + Benefits + Bonus

Two positions available:

  • Full-time, permanent
  • Full-time, 12-month fixed term contract

If you are a pharmaceutical quality assurance professional experienced in supporting quality management 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:

As QA Specialist for Quality Management Systems, you will provide a quality support to the Quality Systems, Operational Quality and Technical Quality teams as required. The department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment. 

Main responsibilities & duties:

  • Ad hoc quality support and communication of risks
  • Completion of assigned Quality and Technical Agreements to eliminate any overdue
  • Tracking and following up on all outstanding assigned Quality and Technical Agreements
  • Completion of assigned internal and external audits
  • Participating in reviews of OOS and RCAs in a timely manner and timely escalations to HOQ/QP as required
  • Timely working with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer Audits and Internal Audit CAPAs
  • Successfully participating in internal audits on a bi-annual basis to cover all areas of the business
  • Providing Quality Operations support to approved vendors and ensure that any risks are communicated effectively
  • Reviewing pharmaceutical product batch files for timely release by Responsible Person (RP) or certification by Qualified Person (QP)
  • Providing QA support to the business during root cause analysis investigation
  • Raising in a timely manner, on request or using own initiative, Third party notification, CAPA, Deviation and Change Control
  • Supporting activities required to effectively maintain the company Pharmaceutical Quality System
  • Monitoring alerts for potential overdue for Complaints, CAPA, Deviation and Change Control
  • Timely completion of Ad hoc and other tasks as assigned

About you:

You will have previous experience of working in a pharmaceutical Quality Department across manufacturing, API, solid dosage forms, liquids, creams, and sterile products. We are also looking for:

  • Bachelor’s degree in Pharmaceutical Science or equivalent
  • An additional advanced degree or diploma is desirable
  • Excellent working knowledge of GMP, SOPs as well as EU GMPD and ICH guidelines
  • Experience of facilitating OOS and Root Cause Analysis
  • Experience of routinely preparing Quality and Technical Agreements
  • Excellent communication skills, both written and verbal
  • Flexible approach and positive attitude to work

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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