Area Lead

Job: Area Lead

Experience: 15 years

Job Description

• Would like to help making complex biopharma facilities more sustainable.
• Driving the project with Science and Risk based Validation (SRV) concept.
• Work very closely with our customers.
• Have strong leadership qualities to lead a team of C&Q Engineers and understanding on stakeholders management at lead role.
• Have knowledge of process equipment’s systems
• Lead C&Q activities with multiple stakeholders like (Engineering responsible Design consultant Vendor’s and QA) of the project organization:
• Align quality and validation concept with customer’s quality system & validation concept
• Define scope of C&Q activities in project and scope of work within quality work package incl. relevant C&Q activities
• Ensure changes to scope are brought to the attention of Project Management.
• Ensure interfaces to and coordination with other disciplines
• Review work of project members in the quality work package.
• Generate validation deliverables like IQ OQ PQ protocols and reports etc.
• Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
• Conduct followup on QAP planned C&Q activities.

Preferred Equcation & Experience

• Bachelor’s or master’s degree in a relevant science engineering or pharmaceutical field.
• 15 years experience performing commissioning and / or qualification activities in an FDA regulated industry.
• Ideally you will already have experience in equipment qualification.
• Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA EU GMP Annexure 11 & 21 CFR 11 and ICH guidelines.