About the role

Quality Assurance specialist ensuring GMP compliance in pharmaceutical manufacturing. Responsible for overseeing sterile manufacturing practices and continuous quality improvement on the production floor.

Responsibilities

Responsible to ensure quality products are manufactured and packaged according to Good Manufacturing Practices (GMP) and established Standard Operating Procedures (SOP)
Provide continuous quality oversight on the production floor to support real-time, compliant decision-making
Serve as QA Subject Matter Expert for aseptic practices during sterile manufacturing
Perform routine inspections of production and packaging areas to ensure adherence to established standards and procedures
Initiate, lead, and support deviation investigations, non-conformances, and CAPA implementation to ensure timely, compliant resolution
Review and approve production and batch documentation, focusing on sterile manufacturing records and data integrity
Coach and mentor production and quality personnel on aseptic practices and GMP expectations

Bachelor of Science degree or equivalent in a related discipline or College Diploma in a related discipline
Strong working knowledge of GMP, cGMP, HPFBI and FDA requirements
Strong working knowledge of compliant aseptic practices, contamination control, and environmental monitoring
Excellent written and verbal communication skills in English
Demonstrated experience in leading and motivating personnel by influencing without authority within a fast paced environment towards a common goal(s)
Strong computer skills, good organizational, inter-personal and communication skills
Flexibility to work in day and night 12 hours continental shifts in rotation (7 Days & 7 Nights Per month)