3 дня назад
Validation & Equipment Compliance Manager (Pharmaceutical Manufacturing)
52 000 - 65 000€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Validation & Equipment Compliance Manager (Pharmaceutical Manufacturing): Leading site validation, equipment qualification, computerized system validation, and GMP compliance for API and finished-product manufacturing in Parma, with an accent on regulatory oversight, data integrity, and lifecycle management. Focus on coordinating risk assessments, approving validation documentation, managing CAPA and change control activities, and driving continuous improvement across manufacturing and laboratory systems.
Location: Parma, Italy
Salary: €52,000–€65,000 per year, plus annual bonus eligibility and benefits.
Company
is an international research-focused biopharmaceutical group operating in more than 30 countries, with global manufacturing and supply operations across pharmaceutical production, engineering, quality, and supply chain management.
What you will do
- Provide Quality oversight and formal approval for qualification and validation activities across equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments.
- Lead the site Validation Program and oversee equipment and system lifecycle management, including qualification, maintenance, calibration, and validation change control.
- Review and approve validation documentation such as URS, DQ, FAT, SAT, IQ, OQ, PQ, PV, VPP, VFR, and the Validation Master Plan.
- Ensure GMP, regulatory, Data Integrity, and Computerized System Validation compliance across API and finished-product manufacturing operations.
- Coordinate risk assessments, process validation, cleaning validation, CAPA activities, inspections, audits, and regulatory submissions.
- Manage team planning, objectives, training, safety, departmental budgets, and continuous improvement initiatives.
Requirements
- Bachelor’s or Master’s degree in a scientific or engineering discipline such as Chemistry, Pharmaceutical Chemistry and Technology, or Engineering.
- 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing, Engineering, Production, Process Technology, QA Validation, Technical Services, or Quality Assurance.
- Extensive experience validating and qualifying equipment and systems in cGMP-regulated environments.
- Strong knowledge of EU and FDA regulatory requirements, with experience supporting FDA/DEA or similar regulatory inspections.
- Experience managing validated or qualified systems, multiple projects, risk assessments, and compliant technical solutions.
- Strong decision-making, accountability, teamwork, interpersonal, and cross-functional collaboration skills.
Nice to have
- Experience in cleaning validation.
Culture & Benefits
- Benefit Corporation and certified B Corp focused on sustainable innovation, reliability, transparency, and ethical behavior.
- Training, development resources, and coaching opportunities.
- Pension, private medical insurance, wellbeing programs, and flexible benefits.
- Work-life balance initiatives, flexible working arrangements, remote work options, and tax assistance services for foreign colleagues.
- Relocation support is available.
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