Spécialiste Assurance Qualité | Quality Assurance, Specialist

Organon•Kirkland, QC

About The Position

The Quality Assurance Specialist (QA Specialist) is responsible for ensuring that all products are manufactured, packaged, tested, released, stored and distributed in accordance with Organon's requirements as well as the regulations in force.

Requirements

Organon delivers ingenious health solutions that enable people to live their best lives.
We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for.
We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background.
We are committed to creating an inclusive environment for all our applicants.

Responsibilities

Inspect finished products, packaging components, and printed materials.
Carry out the compliance document review of finished products, packaging components, intermediates, APIs and printed material and proceed to batch disposition.
Review and finalize the investigations of product quality complaints within the prescribed time frames.
Coordinate the introduction of new products.
Conduct annual review of finished products.
Coordinate and document deviations as well as the investigation of non-conformities.
Develop and update the specifications for the products distributed as well as the specifications for submission.
Write and update procedures related to GMP activities.
Initiate and assess change controls.
Review Technical Quality Agreements (TQAs) with suppliers and maintain the database of Supplier data.
Support audits of external suppliers as well as those of Organon Canada.
Coordinate rework activities and prepare protocols.
Issue and perform impacts on analytical change controls.
Review stability reports and validation evidence.
Generate KPIs related to GMP activities.
Ensure that retention samples are stored in accordance with GMP.
Issue certificates associated with the distribution of biologics products.
Perform product impact assessments following temperature excursions.
Conduct visits to the supplier for audit or continuous improvement purposes.
Maintain evidence of compliance of foreign sites in compliance with Canadian regulations.
Evaluate and/or release products in accordance with all applicable procedures and regulations.
Obtain all GMP documentation as prescribed by Canadian GMP.
Develop the confirmatory testing plan for the products and ensure that the plan is followed.
Ensure that testing laboratories are in possession of the analytical methods in place, and facilitates their supply of analytical standards and other Organon reagents.
Perform full batch record review.
Carry out inspections of finished products prior to disposition.
Coordinate product testing by Health Canada.
Perform and oversee the complaints system.
Ensure that all product complaints are classified, investigated, documented and conducted as per Organon timelines and procedures.
Document all steps of complaint investigation in electronic systems or paper when required.
Collaborate with DPOC and Pharmacovigilance in the training of service providers involved in the management of complaints and adverse reactions.
Monitor and control quality systems.
Any other duties assigned by the supervisor.
Scan and archive files.
Monitoring and compliance with all ALCOA principles related to data integrity.
Promote continuous improvement principles; MPS, Six Sigma.
Problem solving.
Participate in Organon's MPS processes: Third-Party, Kaizen, Kata.
Participates in all Safe by Choice activities and acts as an ambassador for the principles of Occupational health and safety.