AddressBasildon, 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!
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.
Our core behaviours are:
- We act decisively but we never compromise on quality.
- We keep our promises and do as we say.
- 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.E., India, Singapore, Italy, and South Korea.
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.
Pharmanovia’s therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.
About the role:
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. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.
Main responsibilities & duties:
- Perform distributor Audits and progress QTAs with distributors
- 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
- Raise on request or using own initiative Third party notification, CAPA, GDP issues, Deviation and Change Control
- 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
- Compliant review of batch documents in preparation for QP RPi, or RP release
- Completion of assigned Quality and Technical Agreements to eliminate any overdue
- Track and follow up on all outstanding assigned Quality and Technical Agreements
- Participate in internal and external audits
- Participate in reviews of OOS and RCAs in a timely manner, with timely escalations to HOQ/QP as required
- Work with relevant stakeholders to achieve timely completion of all CAPAs relating to Customer and Internal Audit audits
- Ad hoc quality support, communication of risks, and other tasks as assigned
About you:
Candidates with proven relevant experience gained within a pharmaceutical quality department are likely to have the skills required to be successful in this role. We are also looking for:
- Bachelor’s degree in Pharmaceutical Science or equivalent
- Postgraduate degree or diploma is desirable
- Great IT skills including MS software/programs
- Experience gained in manufacturing, API, solid dosage forms, liquids, creams and sterile products
- Experience of facilitating OOS and Root Cause Analysis
- Routine preparation of Quality and Technical Agreements
- Good working knowledge of current GMP, SOPs, EU GMDP and ICH guidelines and regulations
- Previous auditing experience would be an advantage
- Excellent time management and organisational skills with demonstrated ability to juggle multiple competing tasks and demands
- Ability to work successfully within cross-functional teams as well as independently
- Excellent professional communication skills, both written and verbal
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.
