- 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.
- 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).
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Description
Functions, Duties, Tasks:
Minimum Qualifications (education, experience and/or training, required certifications):