Executive / senior industry position
DETAILED DESCRIPTION Of KEY RESPONSIBILITIES:
- Work with Global Quality and EHS to develop, revise and enhance various policies and standard operating procedures (SOPs) in accordance with cGMP, FDA CFR Title 21 Parts 210-211, EU commission and ISO regulatory standards.
- Ensure Teva’s scope and content of engineering quality and compliance policies such as maintenance, calibration, validation, facilities equipment and utilities are in accordance with industry best practices and guidelines (e.g, ISPE).
- Standardize the approach, methodology and templates for equipment and systems validation, installation, qualification, calibration and maintenance.
- Cooperate and align with the GE Segments BP for site implementation of the different engineering quality policies, standards, processes and programs.
- As needed, review and approve engineering documents for relevancy, clarity, proper specifications, tolerances, dispositions, and GDP (Good Documentation Practice).
- Support investigations of non-conformance/deviations (out-of-tolerance and out-of-specification), risk assessments, CAPAs, change controls, and root-cause analysis activities at the segment and site level.
- Manage local and global stakeholder interfaces (e.g., SC, QA, EHS, HR, Finance), to ensure GE regulatory and compliance processes are in alignment and creates synergy with other business processes throughout the organization.
- Education: B.A / Bsc. degree in Engineering (Mechanical / Electrical / Chemical / Industrial) and / or M.A / Msc. degree in Engineering –Must
- Experience in the pharmaceutical/chemical industry –Must
- Experience: 10+ year within quality or engineering support and management functions (facility quality assurance, calibration / metrology, validation / qualification) within FDA, EU commission, ISO regulated industries –Must
- Knowledgeable and good familiarity with FDA/CFR Title 21 Parts 11, 210-211,820, cGMP/GDP, ISO (14644, 9001, 13485, 17025) and other various regulatory standards - Must
- Experience in global, large, complex, multi-level organizational interfaces –Must
- Excellent understanding of global function role and the interrelationships with the local manufacturing sites –Must
- Global, multinational experience –Advantage