GMP Validation Specialist

Hyper Recruitment Solutions; Woking; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading Biopharmaceutical company is seeking a GMP Validation Specialist to ensure compliance with industry standards. You will develop the Validation Strategy, execute qualification activities, and support audits. Ideal candidates will have a relevant life sciences degree and experience in GMP and validation methodologies. Join a dynamic team in Surrey offering a pivotal role in maintaining facility compliance and ensuring regulatory standards are met.

Qualifications

• Relevant degree in life sciences or a related field.
• Proven industry experience in GMP principles and validation methodologies.
• Practical experience with drafting SOPs and conducting risk assessments.

Responsibilities

• Develop and maintain the Validation Strategy.
• Execute qualification and validation activities including DQ, IQ, OQ, PQ.
• Draft and update SOPs and validation protocols.
• Support internal and external audits during validation.

Skills

GMP knowledge

Validation methodologies

SOP drafting

Risk assessments

Education

Relevant degree in life sciences

Job description

ROLE OVERVIEW

We are supporting a leading Biopharmaceutical company who are seeking a GMP Validation Specialist to join their team based in Surrey. As the GMP Validation Specialist, you will play a pivotal role in ensuring the compliant status of the facility, equipment, utilities, and scientific process systems.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the GMP Validation Specialist will be varied; however, the key duties and responsibilities are as follows :

1. Support the development, implementation, and ongoing maintenance of the Validation Strategy, ensuring alignment with regulatory expectations and industry best practices.
2. Coordinate and execute qualification and validation activities across the facility, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
3. Draft and update Standard Operating Procedures (SOPs), validation protocols, and reports, translating regulatory requirements into practical and clear procedures.
4. Act as a key point of contact for external suppliers, contractors, and service engineers during validation and qualification work, supporting internal and external audits and regulatory inspections.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the GMP Validation Specialist, we are looking to identify the following on your profile and past history :

1. Relevant degree in life sciences or a related field.
2. Proven industry experience in GMP principles and validation methodologies.
3. A working knowledge and practical experience with drafting SOPs, validation protocols, and conducting risk assessments.

Key Words

GMP / Validation Specialist / Quality Assurance / CVIM / Process Team / Validation Strategy / Qualification Activities / Regulatory Compliance / SOPs / Risk Assessment / Life Sciences

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.