QA Associate

Operational activities and Quality System Management

 

Documentation:

• 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.

Change control:

• Initiate, assess and/or approve Change Controls related to distribution activities and repackaging activities.

 

Returned products

• Collaborate with Operations and Customer Service for disposition on products returned from customers.

Q-shipment

• 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.

 
Improvement

• 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.

 
Project

• 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).

 

Supplier Management

• Coordinate the supplier management activities (including suppliers approval and maintenance of compliant state).

 

Repack activities

• 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

Knowledge

• Current Good Manufacturing, Documentation & Distribution practices.
• QA related experience within an operational pharmaceutical environment.

Degree

• Master degree

Languages 

• French
• English

Specific know how of systems

• SAP
• Trackwise
• Docspace
• Compliance wire
• Microsoft Office applications