Senior Biologics Combination Products Validation Manager (m/f)

REFERENZNUMMER:

264810/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist