Quality Assurance Officer (F/M)

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Position Status : This is a fulltime permanent position. The role has been approved and is intended to be filled as part of our current workforce planning. Operational Quality Specialists (OQS) ensure Bora’s products and processes meet established quality standards. They provide quality support to a myriad of areas such as deviations, change controls, complaints, GEMBAs, validation, batch record review and release.

Note: This role supports all manufacturing and packaging activities at the site. The successful candidate will be based on the floor to drive and support on-the-floor quality for the site by-
Engaging and mentoring all personnel involved in GMP activities to ensure the site is always inspection ready.

Prepare and implement quality assurance procedures (such as SOPs) and be responsible for reviewing as required.
Participate in investigation of complaints, deviations, and product incidents ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs.
Review batch records and associated documentation, releasing or rejecting batches as per quality procedure.
Participate in improvement projects for Quality systems and other special projects and initiatives, including new product introductions, significant changes to equipment/systems, etc.
Coordinate planned changes initiated by various business units, suppliers, as well as customers and ensure relevant quality procedures are followed.
Accountable for team and site metrics.
Participate in inspections including roles such as hosting, mission control, auditor, auditee, etc.

Bachelor’s Degree in Science, Engineering or related field or equivalent on-the-job experience through years of service.

Experience in Operational Quality Assurance or related role with similar responsibilities; Adequate knowledge of regulatory framework and demonstrated ability to make informed decisions.
Demonstrated ability to participate in projects or change initiatives with the ability to make sound quality decisions.
Excellent technical report writing and reviewing skills.

Work Timings – Morning shift (7am-3pm), with periodic (one) afternoon shift rotation (3pm-11pm) approximately once a quarter.

• Working within the production and office environment.
• On-site.

Updates regarding application status may be communicated via email or through the online applicant profile, where applicable.
These tools do not make final hiring decisions. Competitive salary and performance-based incentives

• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer contributions
• Paid time off and flexible work arrangements
• Employee Assistance Program and Mental Health Resources

We’re proud to be an equal opportunity employer, committed to building a diverse and inclusive workplace where everyone feels empowered to contribute and grow. If you require accommodation during any stage of the application or interview process, or if you’d like to learn more about our accessibility policies, please contact us at View email address on canada.jobradars.com.