Job Title- Documentation Specialist II (9532046)

Location- Toronto, ON

Duration- 4-6 Months (Possible Extension)

Responsibilities-

Create and update mBPRs :

Design / Re-design mBPRs that are efficient, effective, and compliant : ensure the technical components of the mBPRs conform to manufacturing procedures, master specifications, and GxP requirements.

Make decisions and interpretations within broadly defined requirements and clearly communication cGMP requirements.

Optimize and standardize mBPRs : seek opportunities to improve recording of manufacturing data and maintain the database of standard objects.

Drive standardization of manufacturing methods across similar processes : provide guidance in data recording requirement and coordinate and facilitate discussions in the development of mBPRs with all stake holders.

Interact successfully within the highly energized production and regulatory environments.

Maintain the mBPR and associated supplements for printing packages in the Electronic BPR Management System

Ensure accuracy and timeliness for the updates and maintenance of mBPRs.

Skills-

Strong interpersonal, verbal and written communication skills.

Experienced in using different application / softwares for document updates.

Education requirements-

A minimum of a B.Sc degree in Life Science-related field (e.g. Biology, Biochemistry, Biotechnology, Pharmacology, Chemical Engineering and Health Science).

4 6 year experience and understanding of manufacturing / testing environments in the pharmaceutical Biotech Industry, and computerized systems.