Senior Validation Specialist - Hybrid GMP Qualification

ProductLife Group; Parma; Ibrido; EUR 45.000 - 66.000; Tempo pieno

Descrizione del lavoro

ProductLife Group is hiring in Parma, Italy for a Qualification & Validation professional focused on IQ/OQ/PQ activities across facilities, utilities, and equipment. The role requires working with cross-functional teams to ensure GMP compliance and thorough documentation, including validation protocols, reports, and SOPs.

The candidate should have a relevant degree and 3+ years of GMP validation experience, with strong technical writing and MS Office 365 skills.

Competenze

• Bachelor's or Master's degree in engineering, life sciences, chemistry, or pharmacy.
• 3+ years of relevant experience in qualification and validation.
• Experience in GMP-regulated facility, utility, and equipment qualification.
• Strong technical writing and GMP documentation skills.
• Proficiency in Microsoft Office 365.

Mansioni

• Plan, execute, and document IQ/OQ/PQ for facilities, utilities and equipment.
• Prepare and review validation protocols, reports, and related docs.
• Coordinate qualification and validation activities ensuring timely execution and review.
• Ensure compliance with GMP requirements and internal quality standards.
• Support change controls, deviations, CAPAs, and risk assessments related to validation.
• Collaborate with QA, Production, Engineering, and QC teams on validation projects.
• Maintain validation documentation and ensure validated state of equipment and processes.
• Draft Validation Master Plan and SOPs; perform risk analyses.

Conoscenze

Detail oriented

Team leadership

Teamwork

Analytical thinking

Interpersonal skills

Stakeholder management

Travel flexibility

Formazione

Bachelor's/Master's in Engineering or Life Sciences/ Chemistry/ Pharmacy

Strumenti

MS Office 365

Descrizione del lavoro

ProductLife Group is hiring in Parma, Italy for a Qualification & Validation professional focused on IQ/OQ/PQ activities across facilities, utilities, and equipment. The role requires working with cross-functional teams to ensure GMP compliance and thorough documentation, including validation protocols, reports, and SOPs.

The candidate should have a relevant degree and 3+ years of GMP validation experience, with strong technical writing and MS Office 365 skills.