The Company
Our client is one of the leads from the Biotechnology industry who try to improve patients’ lives, by distributing their medicines to hospital and pharmacies in 100 different countries in the world, to over 10 million patients, in Europe, Turkey, Middle East and Africa Regions
Role Description
As a Sr. Associate QA – Product Complaint Inspection, you will perform product complaint assessments, manage deviations, and ensure compliance with GMP/GDP standards. You’ll support complaint investigations, maintain QA documentation, and collaborate with global quality teams to uphold product quality and regulatory standards.
Responsibilities
- Conduct complaint assessments in accordance with internal procedures, regulatory guidelines, and business goals.
- Take ownership of minor deviations related to Product Complaint Inspection (PCI) activities and act as a primary QA contact.
- Manage training materials and work instructions associated with PCI processes.
- Prepare and maintain departmental performance metrics and dashboards.
- Support complaint investigations by performing assessments such as return sample inspections and safety feature verifications.
- Collaborate with corporate quality surveillance teams, other site assessors, and external partners to resolve product complaint issues.
- Review, develop, and approve procedures and work instructions to ensure compliance with company and regulatory standards.
- Participate in continuous improvement projects and provide training to staff on investigation and assessment procedures.
Requirements
- MBO or Bachelor’s degree in Life Sciences or a related field; equivalent experience considered.
- At least 2 years of practical experience in GMP and quality assurance within the pharmaceutical industry.
- Knowledge of GMP, GDP, complaint management, deviations, and quality systems.
- Fluent in English, with strong communication skills.
- Experience with investigations, deviations, and quality systems is a plus.
Other Information
Apply to our vacancy for more information. looking forward to hearing from you.
56521
Similar jobs
Sr. Associate QA – Product Complaint Inspection
Location: Breda, Noord-Brabant
Sector: Biotechnology
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.