Senior QA Officer, Pharmaceutical

Russell Taylor Group Ltd; England; On-site; GBP 35,000 - 45,000; Full time

Job summary

An established industry player is seeking a Senior QA Officer to join their dynamic team in Stevenage. This role offers the chance to oversee quality management and assurance processes for pharmaceutical products, ensuring compliance and excellence in a growing company. You'll be responsible for maintaining and improving the Quality Management System (QMS), investigating complaints, and conducting audits. If you have a passion for quality assurance and a degree in a STEM field, this opportunity is perfect for you. Join a company that values innovation and quality in the pharmaceutical sector.

Qualifications

• Experience in batch review and release in a pharmaceutical setting.
• Strong interpersonal and communication skills are essential.

Responsibilities

• Oversee quality management and assurance for pharmaceutical products.
• Conduct internal audits and support site GMP training as required.

Skills

GMP QA experience

Root Cause Analysis

Interpersonal skills

Communication skills

Batch review and release

Education

Degree in a STEM-related subject

Tools

Fishbone diagram

5 Whys

Job description

Senior QA Officer, Pharmaceutical

Location: Stevenage (fully onsite x5 days a week)

Type: Permanent

Salary: £35,000 - £45,000 depending on experience; possible scope for exceptional candidates

Company Overview

Russell Taylor Group is working exclusively with an established pharmaceutical manufacturing company seeking an experienced Senior QA Officer to work closely with the QA Manager and deputize when needed. This is an exciting time to join a growing company committed to developing its Quality Management System (QMS) and fostering a positive change culture.

The Role

1. Oversee quality management, assurance, and auditing related to pharmaceutical products.
2. Ensure products are fit for purpose before release or sale.
3. Maintain and improve QMS performance, including managing deviations, CAPA, and change control processes in compliance with internal procedures.
4. Investigate and communicate customer or supplier complaints satisfactorily.
5. Handle customer requests and queries promptly according to company procedures.
6. Participate in and host internal and external audits, including regulatory audits.
7. Author and approve routine QMS activities.
8. Perform Root Cause Analysis using tools like Fishbone and 5 Whys.
9. Draft, review, and approve controlled documents following procedures.
10. Support site GMP training as required.
11. Conduct internal audit programs.
12. Support maintenance of the site QMS and report relevant KPIs across the site.

The Person

1. Degree in a STEM-related subject.
2. Experience in batch review and batch release.
3. GMP QA experience, ideally in a pharmaceutical setting.
4. Experience with CAPA, deviations, change controls, and internal auditing.
5. Strong interpersonal and communication skills.
6. Excellent written and verbal English skills.

Important Information

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