QA Specialist

WorkLlama, Inc.; Harlow; On-site; GBP 30,000 - 45,000; Full time

Job summary

A global healthcare company is seeking a QA Specialist in Harlow, UK. The role involves ensuring the quality and compliance of Investigational Medicinal Products. Candidates should have pharmaceutical experience and strong problem-solving skills. Opportunities for development and progression are available.

Qualifications

• Experience reviewing GMP Manufacturing and/or Packaging Documentation.
• Ability to make decisions based on GMP principles.

Responsibilities

• Review GMP Manufacturing and Packaging Documentation for clinical trial packs.
• Provide advice on quality matters and process improvement.
• Act as a Customer Complaint Coordinator.

Skills

Attention to Detail

Problem Solving

Communication

Education

Experience within the pharmaceutical industry

Job description

QA Specialist

Overview

GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We are on an audacious journey to impact the health of 2.5 billion people over the next decade. Our R&D division is at the forefront of this mission, dedicated to the discovery and development of groundbreaking vaccines and medicines. We are transforming the landscape of medical research by integrating cutting-edge science and technology and harnessing the power of genetics and new data. By fostering a collaborative environment that unites the talents of our people, we are revolutionizing R&D to pre-empt and defeat diseases. Join us in our commitment to uniting science, technology, and talent to get ahead of disease together.

Position Summary

An opportunity has arisen for a QA Specialist to join the Quality R&D Supply QA/QP group within Research and Development based in Harlow, UK. The successful candidate will have a critical role in ensuring quality and compliance of Investigational Medicinal Products used worldwide. This person will have the opportunity to develop expertise and to gain experience within an R&D environment. It is a fantastic role that offers a wide range of development and progression opportunities depending on your passion.

Key Responsibilities

• Review GMP Manufacturing and/or Packaging Documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements.
• Provide advice and support to business partner areas relating to quality matters and process improvement.
• Review and assessment of Temperature excursions for IMP shipments.
• Act as a Customer Complaint Coordinator to ensure complaints are progressed

Minimum Qualifications

• Experience within the pharmaceutical industry.
• Strong attention to detail, problem solving skills and ability to learn new skills and apply them.
• Strong communication skills with the ability to build relationships and trust; and to be able to make decisions based on GMP principles.
• Experience working in high pressure environments where there are likely to be conflicting priorities.
• Recent experience of reviewing GMP Manufacturing and/or Packaging Documentation of a range of pharmaceutical dosage forms including sterile products within a Quality Assurance role would be an advantage.
• Proven experience of knowledge of GMP principles and being a decision maker using this knowledge.

Preferred Qualifications

• Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.
• Previous involvement in Quality Deviations/Customer Complaints/Vendor Complaints, Change Controls and inspections/audits
• Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Inclusion at GSK

GSK is an EqualOpportunity/AffirmativeAction Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

If you need any adjustments in the recruitment process, please get in touch with our Recruitment team([e-mail]) to further discuss this today.

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