Senior Quality Assurance and Compliance Officer

N D Oliver & Co Ltd; Bristol; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading life sciences company in Bristol is seeking a Quality Assurance (QA) and Compliance Officer. This role involves ensuring compliance with Quality Management Systems and GMP regulations, conducting audits, and maintaining quality documentation. The ideal candidate will have a relevant degree and significant experience in QA within the pharmaceutical or biotech sectors, along with strong teamwork and problem-solving skills.

Qualifications

• Significant experience in QA or Quality Systems within pharmaceutical or life sciences.
• Experience in a cGMP environment and knowledge of ISO standards.
• Internal auditor experience for ISO 9001/ISO 13485.

Responsibilities

• Ensure compliance with Quality Management Systems and GMP regulations.
• Assist with Quality System audits and maintain Non-Conformances systems.
• Create Standard Operating Procedures (SOPs) and participate in regulatory audits.

Skills

Attention to detail

Teamwork

Problem-solving

Time management

Communication

Education

BSc/BA in biology, chemistry, biochemistry, bioengineering, or related life science field

Job description

Bristol

Permanent

We are working with a global life sciences company with a location in Bristol, seeking a GMP-experienced Quality Assurance (QA) and Compliance Officer.

The company is a leading developer and manufacturer of life science reagents, with a growing QA department supported by recent investments, including a new GMP manufacturing facility.

The role involves compliance activities related to Quality Management Systems and GMP.

What You'll Do

1. Ensure compliance with Quality Management Systems, ISO 9001, and GMP regulations.
2. Assist with Quality System audits at the Bristol site.
3. Maintain Non-Conformances and Corrective Actions systems, working closely with colleagues to manage and close these effectively.
4. Administer QA documentation and change control processes.
5. Gather and analyze Quality Assurance data.
6. Assess data against KPIs to monitor the effectiveness of quality management systems.
7. Create Standard Operating Procedures (SOPs).
8. Participate in regulatory audits.
9. Train colleagues in QA and keep QA training materials up to date.
10. Engage in regulatory compliance activities as needed.

Your Background

1. BSc/BA in biology, chemistry, biochemistry, bioengineering, or related life science field.
2. Significant experience in QA or Quality Systems within pharmaceutical, medical device, life sciences, or biotech sectors.
3. Experience working in a cGMP environment, familiar with EudraLex Volume 4, Part II, or 21CFR part 820.
4. Knowledge of ISO 9001 or ISO 13485 standards.
5. Internal auditor experience for ISO 9001/ISO 13485 and cGMP.
6. Experience investigating customer complaints and providing technical support.
7. Experience with customer and regulatory audits.
8. Proficiency in reviewing CAPA, non-conformances, and deviations.
9. Ability to analyze data against KPIs and report trends to top management.
10. Experience managing documentation systems and change control from a QA perspective.
11. Experience in supplier quality processes.

We seek candidates with excellent teamwork skills, a methodical, process-oriented approach, and strong attention to detail. Effective time management, communication skills, problem-solving abilities, and a positive attitude are essential.

LiCa Scientific is acting as an employment agency for this role.