Senior QA Specialist ( Qualified Person) at Sekisui… · Location…

Senior QA Specialist ( Qualified Person)

Sekisui Diagnostics is looking for a Skilled Qualified person (QP) to join our team in the QA Department in Kent

You:

As a qualified person, you will be responsible for ensuring all biologic drug substance batches are manufactured, reviewed, certified and released in full compliance with EU/UK GMP requirements and company quality standards. You will provide expert quality and regulatory oversight across manufacturing operations, supporting inspections, audits, quality agreements, training and continuous improvement activities. Working closely with cross-functional teams, you will identify and mitigate compliance risks, maintain the Manufacturing and Import Authorisation (MIA(IMP)), and help drive a culture of quality, regulatory excellence and operational compliance. You will also act as a mentor and subject matter expert, supporting the development of future Qualified Persons while ensuring adherence to MHRA, FDA, ISO and other applicable regulatory requirements.

Responsibilities may include:

• Support maintaining Sekisui's UK Manufacturing and Import Authorisation (MIA(IMP))
• Support hosting regulatory inspections and customer audits
• Support preparing and reviewing GMP contracts and Quality/ Technical Agreements
• Maintain up‑to‑date knowledge of relevant laws, regulations, and guidance, and communicate any changes that may impact Sekisui’s operations.
• Complete Continuous Professional Development (CPD) activities to ensure ongoing compliance with current GMP regulations and standards
• Fulfil all duties in accordance with the Code of Practice for Qualified Persons in the Pharmaceutical Industry
• Provide support and mentorship to a designated Sekisui employee with the objective of developing them toward eventual QP qualification
• Support conducting internal audits and supplier audits
• Delivering cGMP training to personnel

To be successful in the role:

• You must have at least two years’ experience as a Qualified Person (QP) in biological drug substance or sterile manufacturing
• Experience in biologics manufacturing
• Excellent verbal and written communication skills with good attention to detail

You must be eligible to act as a Qualified Person (QP) under UK legislation and recognized by MHRA through one of the joint Professional Bodies (Royal Pharmaceutical Society, Royal Society of Chemistry, or Royal Society of Biology)

Who we are:

At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done - focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.

Sekisui Diagnostics offers a competitive compensation and benefits package

Equal Opportunities: As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, colour, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.

Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.