QA Specialist with GMP

Jas Gujral; Stevenage; On-site; GBP 45,000 - 50,000; Full time

Job summary

An established industry player is seeking a QA Specialist for a 12-month fixed-term contract. This role involves ensuring compliance with regulatory standards while supporting a facility expansion project. The ideal candidate will have extensive experience in sterile manufacturing processes and a strong understanding of EMA and FDA regulations. You'll work collaboratively with a multidisciplinary team, acting as a key liaison for quality interactions and promoting a culture of quality throughout the organization. If you're looking for an impactful role in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 5-10 years of experience in a clinical environment.
• Educated to Degree level in a life sciences discipline.

Responsibilities

• Ensure compliance with regulatory standards and facilitate inspections.
• Act as a single point of contact for quality interactions.
• Promote quality awareness and support quality culture.

Skills

Facility Qualification

Cleanroom Qualification

Sterile Manufacturing Processes

EMA and FDA Regulatory Knowledge

ISO 9001 Standards

Quality Assurance Expertise

Interpersonal Skills

GMP Advice

Organizational Skills

Education

Degree in Life Sciences

Job description

QA Specialist - Project Support – 12 month Fixed Term Contract

Our Client is looking to recruit a QA Specialist with at least 5 to 10 years expertise within a clinical environment.

Reporting to and with the guidance of the Head of Quality Assurance, this role will ensure that the manufacturing centre, via proactive engagement, meets the standards and expectations of two key stakeholders; the regulatory authorities and potential collaborators. To work within a multi-disciplinary team to take a tactical role in the governance and oversight of the activity associated with delivering beneficial use to the facility expansion. To act as a single point of contact for all Quality interactions between the manufacturing centre and third-party contractors responsible for delivering the expansion. Participate in the preparation for and the management of regulatory agency and client inspections related to the expansion project. Ensure the PQS is maintained in a fit for purpose state of control for a multi-purpose, multi-client facility and ensure consistency between existing processes and procedures and those associated with the extension. Provide general quality subject matter expertise to the expansion project team. Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes. Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company. Experience must include the following skills: Participation in multidisciplinary project teams with experience in facility and/or cleanroom qualification activity and in sterile manufacturing processes, ideally ATMP’s or biologics. Sound knowledge of EMA and FDA regulatory environments and requirements. Familiar with global standards related to quality e.g. ISO 9001. Experience working as a Quality Specialist or equivalent in biologics and preferably cellular and/or gene therapies. Ability to manage multiple and varied tasks and prioritize workload with attention to detail. Comfortable operating autonomously once goals and objectives are set. Excellent interpersonal, written and verbal communication skills. Confidence and ambition to provide pragmatic and considered GMP advice. Having current and up to date professional knowledge, expertise and best practice. Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives. Ability to quickly establish credibility and build rapport and trust. A good team player, with strong organisational skills. Educated to Degree level in a life sciences discipline. Member of a professional organisation e.g. RSC, SOB, CQI etc. (Desirable).

The Client is based in Stevenage Hertfordshire.

The salary for this position is in the range £45K - £50K.

Please send your CV to us in Word format along with your salary and availability.