Quality Assurance Officer

New Appointments Group Ltd; Stone Cross; On-site; GBP 32,000 - 39,000; Full time

Job summary

New Appointments Group Ltd is partnering with an established pharmaceutical company to recruit a QA Officer on a permanent basis in the Sandwich area. The role focuses on QA support, maintaining the Quality Management System (QMS), and ensuring that pre- and post-production documentation is reviewed and approved prior to batch release.

The ideal candidate will have a minimum of 3 years' QA experience in GMP pharmaceutical manufacturing, strong GMP/GxP knowledge, and proven ability to write clear

Qualifications

• Minimum 3 years' QA experience in GMP pharmaceutical manufacturing.
• Strong GMP and GxP knowledge.
• Experience with QMS, CAPAs, Deviations, Change Controls and batch record review.
• Excellent investigation and problem-solving skills.
• Ability to write clear technical reports and quality documentation.

Responsibilities

• Provide QA support to all departments.
• Maintain and develop the Quality Management System.
• Ensure all pre- & post-production documentation is submitted to QA, checked and approved prior to use of any materials, and batch release.
• Ensure materials meet required specifications.
• Complete QA review and approval of deviations, CAPAs, change controls, complaints, out of specifications and other documentation such as SOPs and forms.
• Assist with internal and external audits.
• Assist with product recalls.
• Ensure quality agreements and quality questionnaires are in place with external companies.
• Manage and develop the company training matrix and complete quarterly reviews on employee training records.
• Participate in weekly QA meetings.
• Ensure investigations are carried out in a timely manner.
• Develop and update logbooks as and when required.

Skills

GMP knowledge

GxP knowledge

Quality Assurance

Investigation & problem solving

Technical report writing

Organizational skills

Communication skills

Job description

We are working with an established pharmaceutical company who are looking to employ a QA Officer, permanently in the Sandwich area.

PLEASE DO NOT APPLY IF YOU DON'T LIVE LOCALLY TO SANDWICH, KENT AND HAVE A FULL RIGHT TO WORK WITH NO RESTRICTIONS (NO GRADUATE VISAS/SPONSORSHIP/RELOCATIONS PLEASE)

This is an exciting full-time permanent position with a salary of up to £35,000/annum and a host of great benefits.

Responsibilities:

• To provide QA support to all departments.
• Maintain and develop the Quality Management System.
• Ensure all pre & post-production documentation is submitted to QA, checked and approved prior to use of any materials, and batch release.
• Ensure all materials meet required specifications.
• Complete QA review and approval of deviations, C.A.P.A's, change controls, complaints, out of specifications and other documentation such as SOP's and forms.
• Assist with internal and external audits.
• Assist with product recalls.
• Ensure quality agreements and quality questionnaires are in place with external companies.
• Manage and develop the company training matrix and complete quarterly reviews on employee training records.
• Participate in weekly QA meetings.
• Ensure investigations are carried out in a timely manner.
• Develop and update logbooks as and when required.

About You:

• Minimum 3 years' Quality Assurance experience within a GMP pharmaceutical manufacturing environment
• Strong understanding of GMP and wider GxP requirements
• Experience of QMS, CAPAs, Deviations, Change Controls and batch record review
• Excellent investigation and problem-solving skills
• Ability to write clear technical reports and quality documentation
• Strong organisational skills with the ability to prioritise multiple activities
• Excellent communication skills and confidence working across all departments

Local candidates need only apply and those with no restrictions on their right to work.

We are committed to fostering a diverse and inclusive environment in line with the Equality Act 2010. All qualified applicants will be considered regardless of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.