Functions, Duties, Tasks:
Adhere to the principles of “safety first, quality always”.
Support blending, concentration and filling according to standard operating procedures, approved Outline of Production/Product Dossiers and to cGMP guidelines.
Complete forms, and batch documentation in a concurrent, accurate and neat manner following good documentation practices (GDP).
Scheduled equipment/instrument maintenance and calibrations are completed on time as per issued work orders.
Operate blend and fill processing equipment within product specifications.
Maintain the cleanliness of the production areas and assist in disinfection procedures.
Preparation and modification of standard operating procedures as required.
Cross train in other departments as required to ensure production continuity.
Cross Train in other processes (when time permits) as needed.
Other duties as required.
Minimum Qualifications (education, experience and/or training, required certifications):
2-year biotechnology diploma is required; a Bachelor's Degree or Post-Secondary education in a life science (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
1-3 years of pharmaceutical manufacturing experience in GMP environment is preferred.
Experience in the preparation of standard operating procedures, preparation of batch records as per specific GMP requirements.
Excellent interpersonal skills, both communications and written.
Outlines of production, cGMP guidelines, and HSE regulations.
Experience performing investigations and writing deviations.
Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point).