Operational activities and Quality System Management
- Write, review and/or approve Work Instructions (WI) and Procedures (SOP)
- Collaborate with other departments for documentation content and ensure
Good Documentation Practices are followed.
- Act as delegate of the Responsible Person for the review and approval of activities listed in DS-FRM-36468 (Responsible Person activities delegation list).
Non- conformities & Complaints:
- Initiate, investigate and/or approve Quality Issues, Correctives and Preventives actions and complaints related to distribution activities and repackaging activities.
- Initiate, assess and/or approve Change Controls related to distribution activities and repackaging activities.
- Collaborate with Operations and Customer Service for disposition on products returned from customers.
- Prepare/approve the required documents to establish shipments under quarantine (i.e : before the final QP release of the products).
Audits & inspections
- Support and actively participate to quality internal/external audits and check rounds.
This include audits preparation, audits completion and audits follow-up.
- Provide data/information for the Quality Improvement Plan (QIP) and Quality Management Review (QMR) meetings
- Review and improve processes of the QMS, ensure that KPIs are in place.
- Participate to the processes improvement as process owner.
QA on the floor
- Support operations to work in compliance with GMP and GDP rules.
Training & Qualification
- Deliver GMP/GDP training to warehouse and repackaging personnel
to ensure operational personnel has an appropriate understanding of the GMP/GDP.
- Review training curricula and create training materials (where applicable).
Recall & Destruction
- Coordinate the recall and destruction processes.
- Participate in the development of projects implementation in collaboration with Operations.
Qualification & Validation
- Coordinate the validation, calibration and qualification of equipment.
- Follow-up activities related to facilities with potential quality impact on products (pest control, temperature monitoring).
- Coordinate the supplier management activities (including suppliers approval and maintenance of compliant state).
- Act as Quality Assurance representative within the Repack team.
- Review and approve GMP documentation, including Batch records, related to repack activities of finished products to ensure that :
o These are free of error,
o These are compliant with GMP and internal requirements
o Material and printed components are compliant prior use.
Batch/products disposition activities
- Assess and change the batch status (product disposition) of customer returns and repacked products, as per DS-FRM-36468 (RP activities delegation list).
- Change the batch status in order to establish shipments under quarantine
(before the final QP release of the products),as per DS-FRM-36468.
- Act as back-up for EDN QA team, for any other batch disposition activities and version management