Senior QA Officer, Pharmaceutical

Russell Taylor Group Ltd; Watford; On-site; GBP 35,000 - 47,000; Full time

Job summary

A pharmaceutical manufacturing company is seeking an experienced Senior QA Officer to manage quality assurance and auditing processes. The ideal candidate will have a degree in a STEM subject and a background in GMP QA, contributing to the development of the QMS. This onsite role offers a salary range of £35,000 - £47,000, depending on experience.

Qualifications

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

Responsibilities

• Responsible for quality management, assurance, and auditing related to pharmaceutical products.
• Ensure products are fit for purpose before release for use or sale.
• Maintain and improve QMS performance by managing deviations, CAPA, change control, and other items.
• Investigate and communicate customer or supplier complaints satisfactorily.
• Address customer requests and queries promptly in line with company procedures.
• Participate in and/or host internal and external audits.
• Author and approve routine QMS activities.
• Perform Root Cause Analysis using tools like Fishbone and 5 Whys.
• Author, review, and approve Controlled Documents as per procedures.
• Support site GMP training as required.
• Conduct internal audits and support maintenance of the site QMS.
• Report relevant KPIs within the department and across the site.

Job description

Senior QA Officer/Principal, Pharmaceutical

Location: Stevenage (fully onsite x5 days a week)

Type: Permanent

Salary: £35,000 - £47,000 depending on experience, with potential scope for exceptional candidates

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 role involves contributing to the development of the QMS and fostering a positive change culture within the company. This is an exciting opportunity to join a rapidly growing organization.

The Role:

1. Responsible for quality management, assurance, and auditing related to pharmaceutical products.
2. Ensure products are fit for purpose before release for use or sale.
3. Maintain and improve QMS performance by managing deviations, CAPA, change control, and other items in compliance with internal procedures.
4. Investigate and communicate customer or supplier complaints satisfactorily.
5. Address customer requests and queries promptly in line with company procedures.
6. Participate in and/or host internal and external audits, including customer and regulatory audits.
7. Author and approve routine QMS activities.
8. Perform Root Cause Analysis using tools like Fishbone and 5 Whys.
9. Author, review, and approve Controlled Documents as per procedures.
10. Support site GMP training as required.
11. Conduct internal audits and support maintenance of the site QMS.
12. Report relevant KPIs within the department and 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.

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