CQV Engineer - 6+ Months - Amsterdam, Netherlands - Pharma Industry

North Holland, Amsterdam  ‐ Onsite

Keywords

Auditing Standard Operating Procedure Regulatory Requirements Risk Analysis Pharmaceutical Production Pharmaceuticals Coaching and Mentoring

Description

Responsibilities:

• Lead commissioning, qualification, and validation activities in accordance with regulatory requirements and company standards.
• Develop and execute commissioning and qualification protocols for pharmaceutical manufacturing equipment, systems, and facilities.
• Collaborate with cross-functional teams to ensure successful completion of projects within specified timelines.
• Conduct risk assessments and implement mitigation strategies throughout the validation process.
• Generate comprehensive documentation, including protocols, reports, and standard operating procedures (SOPs).
• Perform equipment and process troubleshooting during validation activities.
• Provide technical expertise and support during regulatory inspections and audits.
• Mentor and train junior staff members on validation principles and practices.

Requirements:

• Lead commissioning, qualification, and validation activities in accordance with regulatory requirements and company standards.
• Develop and execute commissioning and qualification protocols for pharmaceutical manufacturing equipment, systems, and facilities.
• Collaborate with cross-functional teams to ensure successful completion of projects within specified timelines.
• Conduct risk assessments and implement mitigation strategies throughout the validation process.
• Generate comprehensive documentation, including protocols, reports, and standard operating procedures (SOPs).
• Perform equipment and process troubleshooting during validation activities.
• Provide technical expertise and support during regulatory inspections and audits.

If you are interested, please forward your updated CV to
Start date
ASAP
Workload
100% (5 days per week)
Duration
6 months
(extension possible)
From
Optimus Search GmbH
Published at
26.02.2024
Contact person:
Camille Corremans
Project ID:
2720783
Industry
Medicine and Pharmaceuticals
Contract type
Freelance
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