QA Officer/ Specialist Pharmaceutical

Capio Spine Center Stockholm; Alderley Edge; On-site; GBP 25,000 - 32,000; Full time

Job summary

An established biotech company is seeking a dedicated QA Officer/Specialist to enhance their quality assurance team. This role involves generating and reviewing SOPs, supporting customers with inquiries, and ensuring compliance with GMP standards. The successful candidate will play a crucial role in maintaining quality documentation, participating in audits, and executing the Quality Management System. With a focus on quality improvement initiatives, this position offers a dynamic work environment where your contributions will directly impact product quality and customer satisfaction. If you have a scientific background and a passion for quality assurance, this opportunity is perfect for you.

Benefits

25 days holiday + bank holidays

Private medical insurance

Share options scheme

Company pension

Onsite parking

Qualifications

• Degree in a relevant scientific field with knowledge of GMP.
• Experience in CAPA, Deviations, OOS, OOT, and customer complaints handling.

Responsibilities

• Review and generate SOPs, support customers, and resolve complaints.
• Participate in internal audits and maintain quality documentation.

Skills

GMP Knowledge

Interpersonal Skills

Report Writing Skills

Microsoft Applications

Education

Degree in a relevant Scientific discipline

Tools

Quality Management System (QMS)

Job description

QA Officer/ Specialist - Biotechnology

Location: Cheshire (onsite)
Type: Permanent
Salary: £25000-£32000 (dependant on experience)
Hours: Days (Monday - Friday), parking onsite
Additional: 25 days holiday + BH, private medical, share options scheme, company pension

Our Client a Biotech company is looking to strengthen their QA team and recruit an experienced QA Specialist.

The role:

1. Generation or review of SOPs and other documents (where applicable)
2. Providing support to customers and answering queries and product investigations
3. Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
4. Participate in the internal audit programme to ensure continued GMP compliance of all site activities
5. Utilise scientific resources in order to work on improving quality of products and services
6. Maintain personal training folder in an auditable state
7. Maintain quality documentation system
8. Participate in quality improvement initiatives
9. Support in the process of maintaining and archiving documentation
10. Support and execute external audits where applicable
11. Support management when hosting regulatory audits
12. Work on executing and maintaining the QMS, including but not limited to:
1. Risk Assessments
2. Change Controls
3. CAPAs
4. Deviations
5. Complaints
6. Recalls
7. OOS/OOT

The Person:

1. Will have a Degree in a relevant Scientific discipline
2. Will have good knowledge of GMP
3. Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous
4. Strong IT skills (Microsoft applications)
5. Good interpersonal skills and strong written/verbal report writing skills

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