Senior QA Validation Specialist (Freelance) GMP & Docs

Vivid Resourcing; Limburg; Sur place; EUR 56 000 - 100 000; Plein temps

Résumé du poste

Vivid Resourcing is assisting a global customer in Limburg in finding x3 QA Validation Officers to establish and maintain validation across systems, processes, facilities, and equipment in line with GMP guidelines.

The role focuses on Equipment Validation (30%) and documentation (70%), with several projects implementing new products on the line and sensor updates on machines. Onsite, 40 hours per week, English/Dutch language skills required.

Qualifications

• GMP guidelines, pharmaceutical regulations, microbiology, hygiene, and related quality requirements are expected.
• Experience with quality systems, procedures, and training programmes is required or advantageous.
• Proficient with Microsoft Office tools and capable of writing technical reports.

Responsabilités

• Perform internal audits and support external audits related to validation activities.
• Develop, implement, and maintain validation studies with Operations, Supply Chain, Technical Services, and QA.
• Prepare and maintain documentation for all validation activities and validation results.
• Contribute to continuous improvement of personnel, processes, systems, and procedures.
• Develop and maintain procedures related to validation activities.
• Assess validation requirements from proposed changes to systems, processes, facilities, or equipment.
• Ensure validation activities are initiated and completed in a timely manner.
• Ensure all validation activities comply with GMP requirements.

Connaissances

GMP knowledge

Documentation

Quality systems

Analytical skills

Outils

Microsoft Office

Description du poste

For a global customer in Limburg, we are searching for x3 QA Validation Officers. The purpose of this position is to establish and maintain the validation of systems, processes, facilities, and equipment at the required standard within the organisation. This must be carried out in accordance with legal requirements, particularly pharmaceutical regulations and GMP guidelines, while working with customers' quality representatives to develop appropriate validation strategies where necessary.

Candidates do not need to have explicit GMP experience but should be well versed in Equipment Validation (30%) and documentation (70%). There are several ongoing projects where you will oversee the implementation of new products on the Line, and new sensors on machines etc.

Key Responsibilities

• Perform internal audits and support external audits (internal, customer, and notified body audits) related to validation activities.
• Develop, implement, and maintain validation studies in collaboration with Operations, Supply Chain, Technical Services, and Quality Assurance.
• Prepare and maintain documentation for all validation activities and validation results.
• Contribute to the continuous improvement and optimisation of personnel, processes, systems, and procedures.
• Develop and maintain procedures related to validation activities.
• Assess validation requirements resulting from proposed changes to systems, processes, facilities, or equipment.
• Ensure validation activities are initiated and completed in a timely manner.
• Ensure all validation activities comply with current international validation regulations and Good Manufacturing Practice (GMP) requirements.
• Ensure implemented changes do not negatively affect the validation status of systems, processes, facilities, or equipment.

Profile

• Several years of experience in a pharmaceutical manufacturing environment is an advantage, but not mandatory.
• Good understanding of GMP guidelines, pharmaceutical regulations, microbiology, hygiene, and related quality requirements (can be a similar industry with strict regulations).
• Experience working with quality systems, procedures, and training programmes.
• Proficient in Microsoft Office.
• Experience writing technical reports.
• Motivated and proactive personality.
• Strong sense of ownership and responsibility.
• Able to organise work independently, prioritise effectively, and work well as part of a team.
• Goal-oriented.
• Strong analytical and open-minded approach.

SENIORITY: Medior/Senior

START DATE: September

DURATION: 12 Months+

EXTENSION: Yes

CONTRACT: Freelance or Employment (Consultant)

LOCATION: Limburg

ONSITE POLICY: Onsite

HOURS PER WEEK: 40

LANGUAGES: Fluent Dutch or English

INTERVIEW PROCESS: 2 stages

If you are interested, please forward your updated resume to [e-mail] to be considered.