NL Specialist Quality Assurance

SIRE LIFE SCIENCES; Breda; On-site; EUR 70,000 - 90,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking an experienced Equipment Validation Specialist to join a technical support team ensuring manufacturing equipment and systems comply with GMP standards.

You will lead validation activities on existing production lines, review validation documentation, and support risk assessments and continuous improvement. Flexible to relocate or commute within about one hour for a December start in the Netherlands.

Qualifications

• Minimum of 5 years of professional experience in GMP environments, specifically in equipment validation.
• Strong expertise in equipment validation and documentation review.
• Proven ability to work independently and deliver high-quality results.
• Experience with quality review of validation packages and risk management tools.
• Excellent attention to detail and ability to handle large amounts of technical documentation.
• Strong communication skills and a structured, organized approach to work.
• Comfortable working within a team of junior professionals, providing guidance as needed.

Responsibilities

• Lead and support equipment validation activities independently across existing production lines.
• Review and approve validation documentation, ensuring compliance with internal standards, GMP, and regulatory requirements.
• Support technical documentation and validation deliverables, maintaining accuracy and completeness.
• Assist in risk assessments related to equipment and validation processes, identifying potential issues and mitigation strategies.
• Review validation data, change requests, and validation investigations, ensuring high-quality documentation.
• Collaborate with cross-functional teams, providing technical guidance and ensuring validation processes align with quality policies.
• Support deviation investigations, CAPAs, and continuous improvement activities related to validation.

Skills

GMP compliance

Equipment validation

Documentation review

Risk management

Independent worker

Communication skills

Team guidance

Job description

Company:A dynamic organization operating in the pharmaceutical or biotech manufacturing sector, dedicated to maintaining high standards of quality and compliance across its production processes. The company supports both new-build projects and the ongoing support of existing manufacturing lines, with a focus on innovation and operational excellence.

Job Description:
We are seeking an experienced Equipment Validation Specialist to join a technical support team responsible for ensuring the integrity and compliance of manufacturing equipment and systems. This role involves managing validation activities for existing production equipment, providing expert review, and supporting quality and regulatory standards.

Responsibilities:

• Lead and support equipment validation activities independently across existing production lines.
• Review and approve validation documentation, ensuring compliance with internal standards, GMP, and regulatory requirements.
• Support technical documentation and validation deliverables, maintaining accuracy and completeness.
• Assist in risk assessments related to equipment and validation processes, identifying potential issues and mitigation strategies.
• Review validation data, change requests, and validation investigations, ensuring high-quality documentation.
• Collaborate with cross-functional teams, providing technical guidance and ensuring validation processes align with quality policies.
• Support deviation investigations, CAPAs, and continuous improvement activities related to validation.

Requirements:

• Minimum of 5 years of professional experience in GMP environments, specifically in equipment validation.
• Strong expertise in equipment validation and documentation review.
• Proven ability to work independently and deliver high-quality results.
• Experience with quality review of validation packages and risk management tools.
• Excellent attention to detail and ability to handle large amounts of technical documentation.
• Strong communication skills and a structured, organized approach to work.
• Comfortable working within a team of junior professionals, providing guidance as needed.

Candidates who are motivated by long-term roles, have a flexible approach to relocating or commuting within approximately one hour, and are available for a December start. The initial contract is for 12 months with a strong possibility of extension, supporting a collaborative and innovative work environment.