Sr Associate QA | Product Complaint Inspection (PCI) | BREDA

The role:

Initiate and own Minor deviations related to Product Complaint Inspection (PCI) Area activities.
Own training material related to PCI processes.
Own work instructions related to PCI processes.
Prepare metrics and own and maintain departmental performance boards.
Perform assessments in support of complaint investigations (e.g. Return sample inspection and Safety Features verification).
Partner with corporate product quality surveillance, assessors from other sites and contracted partners to resolve product complaint investigations.
Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
Provide training to staff on performing investigations/assessments.
Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.
Additionally, gain subject matter expertise in product complaint inspections and its related stakeholders.

Qualifications

Minimum Requirements

MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
Knowledge of GMP and GDP with the ability to interpret and apply in both routine and non-routine cases
Knowledge of Complaints Management, Deviations and Quality processes and systems.
Fluent in English

Preferred Requirements:

Acquired practical experience in Good Manufacturing Practice (GMP) over at least 2 years
Acquired practical experience in Quality Assurance or related field in pharmaceutical industry over at least 2 years
Experience in investigations, deviations and Quality systems is a plus.

Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502 for more info. ???????