Description
We are looking for a
Senior Biologics Combination Products Validation Manager (m/f)
Reference: -en
Start: 03/15
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide Quality supervision of process/cleaning validation and qualification activities for the biologics combination products' external Network (Contract Manufacturing Organisations)
- Assess validation methods at CMOs in regard to cGMPs, quality requirements and global standards and practices (Contractor Quality Requirements)
- Review CMO validation/qualification lifecycle documents for equipment, facility and utility qualifications associated with the manufacture of products
- Review and/or approve CMO validation/qualification lifecycle documents for specific processes, for cleaning validations and shipping qualifications
- Prepare and/or approve process validation master plans
- Prepare validation project plans supporting technology transfers to CMOs
- Author and/or review validation related sections of regulatory submissions
- Act as Validation Subject Matter Expert for pre-approval inspections, internal audits, deviations and investigations, change control assessments, site selection and risk assessments
Your qualifications
- Bachelor of Science or equivalent, graduate degree preferred
- In-depth experience in validation and/or process engineering
- Strong knowledge of the global pharmaceutical industry, regulations, standards and guidance documents, specifically with regards to combination products and medical devices
- Ability to communicate clearly and professionally, both in writing and verbally
- Flexibility in working hours and willingness to travel (approx. 20%) to meet business objectives
- Ability to speak English and, preferably, other European languages
Skills:
- Qualification/validation specialist
Keywords: Spezialist Validierung und Qualifizierung