Quality Assurance and Compliance Officer

N D Oliver & Co Ltd; Bristol; On-site; GBP 35,000 - 55,000; Full time

Job summary

A forward-thinking company in the life sciences sector is seeking a Quality Assurance and Compliance Officer to join their growing team in Bristol. This role is pivotal in ensuring compliance with Quality Management Systems and Good Manufacturing Practices, particularly in a newly established GMP manufacturing facility. The successful candidate will engage in various compliance activities, including conducting audits, maintaining QA documentation, and training colleagues. This is an exciting opportunity to contribute to a leading developer of life science reagents, where your expertise will directly impact the quality and safety of products in the market.

Qualifications

• Extensive experience in Quality Assurance within life sciences or biotechnology sectors.
• Knowledge of ISO standards and familiarity with cGMP environments.

Responsibilities

• Ensure compliance with Quality Management Systems and GMP regulations.
• Administer QA documentation and participate in regulatory audits.

Skills

Quality Management Systems

Good Manufacturing Practices (GMP)

ISO 9001

ISO 13485

Data Analysis

Regulatory Compliance

Teamwork

Problem-solving

Education

BSc/BA in Biology, Chemistry, Biochemistry, or Bioengineering

Tools

Documentation Management Systems

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, especially after recent investments in a new GMP manufacturing facility.

The role involves compliance activities related to Quality Management Systems and Good Manufacturing Practices.

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 location.
3. Maintain Non-Conformances and Corrective Actions systems, working closely with colleagues to ensure effective management and closure.
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 degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
2. Extensive experience in Quality Assurance or Quality Systems within pharmaceutical, medical device, life sciences, or biotechnology sectors.
3. Experience working within a cGMP environment, familiar with EudraLex Volume 4, Part II, or 21CFR part 820.
4. Knowledge of ISO 9001 or ISO 13485 standards.
5. Certified internal auditor 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 with documentation management systems and change control from a QA perspective.
11. Knowledge of supplier quality processes.

We seek candidates with excellent teamwork skills, a methodical and process-oriented work style, organization, attention to detail, and effective communication skills. A positive, flexible attitude and strong problem-solving abilities are essential.

LiCa Scientific acts as an employment agency for this role.