Qualified Person

Basildon, Essex (hybrid role: 3 days office, 2 days home per week)

Full-time, permanent position

Salary: Competitive + Benefits + Bonus

If you are an agile, committed, and strategic quality professional, with experience of leading QA teams and eligibility as QP, 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 160 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, Spain, 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

As Qualified Person, in this role you will support a team of quality professionals in ensuring high ethical and quality standards are maintained and perform in accordance with directive 2001/83/EC and Annex 16 of the EU GMP Guide.

You will also provide Quality support and advice for projects, divestments and business processes.

Key skills are a strong working knowledge of EU GMP and GDP, strong leadership and management skills, the ability to communicate proactively, clearly and concisely both internally and externally.

The department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

This role reports into the Director for Quality Operations.

Main Responsibilities & Duties

• Provide QP release activities in line with EU GMP directives and guidance for the Certification of Medicinal Products
• Provide support for the RP release function in line with EU GDP guidance
• Provide GMP support and guidance for Pharmanovia and third parties employed by Pharmanovia
• Review and approve any GMP or regulatory documents as required
• Using the principles of Quality Risk Management, lead Quality Investigations root cause analysis meetings ensuring appropriated Corrective and Preventative actions have been assigned
• Where required undertake the Quality review and approval of SOPs, master GMP related documentation, batch manufacturing records, validation protocols, analytical specifications, change requests, quality reviews, planned changes in accordance with procedure
• Review and approve Technical Agreements
• Maintain up to date knowledge of regulatory requirements, including GMP/GDP, and advise colleagues, business partners & management of implications of current and new requirements
• Actively identify and support site continuous improvement projects
  
  

About You

Candidates with experience of working as a QP within a pharmaceutical environment should have the necessary skills and experience required for this role. We are also looking for:

• Bachelor’s degree in chemistry, biology or pharmaceutical science
• Postgraduate degree in pharmaceutical studies or equivalent is desirable
• Eligible to be added as a QP to an MIA under the permanent provisions of Directive 2001/83/EC for Medicinal Products for Human Use
• Registered as member of either: Royal Pharmaceutical Society, Royal Society of Chemistry or Royal Society of Biology
• Experience working within a Pharmaceutical Company as a Qualified Person releasing Solid Dose products
• Proven experience of hosting and supporting MHRA Regulatory Inspections
• Experience of leading self-inspections and external audits
• Excellent working knowledge and application of Current EU Guide to GMP and EU GDP
• Good working knowledge of Quality Risk Management
• Proven experience of supporting manufacture and packaging of solid dosage forms, liquids, creams and sterile products
• Proven experience of hosting and supporting Regulatory Inspections
• Significant previous experience within Quality Assurance, creating or reviewing policies and procedures, internal auditing, reviewing deviations, change control requests, CAPA etc.
• Experience and confidence in managing teams, understanding of difference between leadership and management
• Excellent communication skills both written and oral, and ability to forge good working relationships with internal and external customers
• Calm, systematic, logical thinker, with ability to focus on priorities whilst coordinating multiple issues
• Commitment to quality, patient safety and achieving the best outcome with a pragmatic and strategic approach
• Excellent time management skills
• Positive attitude and flexible approach 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.