QA Manager, GMP Auditor

Job Description:

Job Specification

We offer:

Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting

Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!

A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!

Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving some of the most difficult scientific challenges”.

We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.

We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully Integrated

Gene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisation

The Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and due to exciting new developments, we are now recruiting for a QA Manager, GMP Auditor.

We offer a competitive salary and a progressive and comprehensive suite of employee benefits

• We offer state of the art working environment in our modern Liverpool site

• We offer the opportunity for growth and development and will support funding for relevant training and development programmes

We do more than manufacture batches, we develop medicines!

Key roles and responsibilities:

• Participating in the risk-based planning and scheduling of audits

• Execute Routine, Due Diligence, For Cause, Assessment, and Non-Routine Request type audits to support CMC project team.

• Engage the appropriate business partners in all stages of the audit process

• Gather data and conducts risk assessments

• Identify the need for additional SME or technical support

• Independently or leading a multi-discipline/functional team:

• Prepare, conduct, and report audits for foreign and domestic sites as assigned

• Initial assessment of audit deficiencies, corrective and preventative actions, and overall site compliance status based on regulatory GMP requirements and specific Allergan requirements

• Escalate and notify management of critical audit findings

• Collaborate with business partners to finalize corrective action plans or mitigation actions and follow up to verify of implementation.

• Maintaining confidentiality of information obtained during audits

• Lead multi-disciplinary audit teams for complex and/or high-risk sites

• Supplier Oversight for high risk suppliers

• Review and approve Quality documentation relating to validation and tech transfer activities

• Provide Quality input into supply chain activities such as approval of new suppliers, raw materials, components and subcontractors

• Apply the quality systems in conformance with Pharmaron policies/procedures to ensure compliance with cGMP in line with all licensed activities

• Assess own workload and discuss with the QA Director any perceived discrepancy between work assigned and ability to complete it.

• Participate in the change control procedure to ensure that all changes affecting the GMP areas in-house or at a third party are controlled to maintain compliance at all times

Qualification

Requirements:

You will perform cGMP audits and assessments of service providers related to research and development project supply chains, which may involve internal and external manufacturing, packaging/labelling, laboratory, suppliers of GMP relevant materials, components, storage & distribution, services and activities supporting clinical manufacture and packaging for human use.

For this role we are looking for: -

• Degree or equivalent in biological or pharmaceutical sciences and substantial experience in a quality related role in a relevant pharmaceutical manufacturing environment

• ASQ Certification or similar certification as a Quality Auditor

• Experience in Pharmaceutical Quality system

• Technical expertise in pharmaceutical validation

• Experience in auditing principles and techniques, inspection requirements, and performing cGMP audits of pharmaceutical suppliers throughout a drug development program

• Knowledge of EU GMPs, Device or Biologic regulations and ICH guidance’s and International Standards (Risk Management, ICH 8, 9, 10)

Why Should You Apply?

• This is an opportunity for you as a QA and GMP professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition, and the desire to grow with the department

• Build and shape your career in an environment that sets and commits to the highest standards of Biologics

• To be part of a team who support each other, embrace, and solve technical challenges and put excellence at the heart of all that we do

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 12,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.