Quality Project Specialist

4 weeks ago


United Kingdom Pharmanovia Full time

Basildon, Essex (hybrid: 3 days office, 2 days home)
Salary: Competitive + Benefits + Bonus
If you are an agile, committed, and innovative quality specialist within the pharmaceutical sphere, then we want to hear from you
Join us to help improve peoples’ lives and make healthcare better for everyone
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.
We value our heritage and foster an entrepreneurial spirit.
We reinvest in our future – in our products, our brands and our people.
We give back to our communities.
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 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, U.A.We are an agile, committed, and innovative 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.
Reporting to the Qualified Person (QP), you will be a key member of the team which is responsible for providing a quality support to the Quality Systems, Operational Quality and Technical Quality teams.
Our Quality Department has an ethos of continuous improvement, refining systems and creating efficiencies. Provide Quality Operations support to approved vendors and ensure that any risks are communicated effectively
Review pharmaceutical product batch files for timely release by Responsible Person (RP), Responsible Person for Importation (RPi), or certification by Qualified Person (QP)
Provide QA support to the business during root cause analysis investigation
Support activities required to effectively maintain the company Pharmaceutical Quality System
Monitor alerts for potential overdue for Complaints, CAPA, GDP issues, Deviation and Change Control
Completion of assigned Quality and Technical Agreements to eliminate any overdue
Track and follow up on all outstanding assigned Quality and Technical Agreements
Ad hoc quality support, communication of risks, and other tasks as assigned
Candidates with proven relevant experience gained within a pharmaceutical quality department are likely to have the skills required to be successful in this role. Bachelor’s degree in Pharmaceutical Science or equivalent
Postgraduate degree or diploma is desirable
Great IT skills including MS software/programs
Experience of facilitating OOS and Root Cause Analysis
Routine preparation of Quality and Technical Agreements
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.
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