· Complaint Management for Netherlands, Nordic countries, CMOs and Third Parties
· Responsible SME for PQR management
· Responsible SME for Training Management system in Sun Europe - Learning Management System
· Support QMS activities related to CAPA, Change control, deviations etc in Track wise software in roles such as initiator/reviewer or approver wherever applicable.
· Support management of SOPs in eDMS software
Level of responsibility:
· Integration of procedures from various systems & processes
· Business support as required
· Deputize for QA Manager as required
· QMS to support upwards of 400 batches per month release by Sun Pharmaceutical Industries Europe BV following importation from Third Country Sun manufacturing locations and CMO's within and outside the EEA. Delegation of Responsibility· To upstream SME’s such as Senior QP or Regional Head of Quality.
· MENTORSHIP: · DAILY OPERATIONS: · SUPPORT OF COMPANY GOALS
· REGULATORY & CORPORATE COMPLIANCE· HARMONIZED QUALITY SYSTEMS· PERFORMANCE OF KEY ROLES AND RESPONSIBILITIES
· ALL-TIME AUDIT READINESS· QMS SUPPORT
Assessment and Planning of Work
Expectation to self-drive these activities to support the business needs
Problems/ Key Features
Full support to all aspects of the QMS through execution and management
Internal: Relevant stakeholders and customers
External: Regulatory Agencies (occasionally)
Technical understanding of manufacturing processes and EU GMP Guidelines.