Job Description

Description :

Oversees the support production teams whose mandate is to investigate all manufacturing and packaging related problems. Offer quick interventions to manufacturing sites (production plant and/or third party) to solve isolated problems related to product packaging, manufacturing or product formulations with goal to limit impact on supply chain. Ensure resolution of quality issues (complaints, investigations, CAPA, etc.), identify and implement process improvements and verifies efficacy of implemented changes.

RESPONSABILITIES & DUTIES

• Manage the interventions to manufacturing sites (production plant and/or third party) to solve isolated problems related to product manufacturing, product formulations or packaging (Royalmount, Candiac and Third parties).
• Recommend changes or improvements to the manufacturing, formulation process or packaging.
• Obtain initiation of changes to manufacturing or packaging masters to implement identified changes and/or initiate project request to validate process based on level of changes.
• Schedule, coordinate and assign priorities to Process Improvement Specialists based on capacity
• Oversees the identification of the products having large volumes in terms of annual production and/or having processes that can be improved in terms of time, cost and quality of the finished product.
• Review and approves investigation reports
• Evaluate potential impacts and approves Change controls
• Evaluate potential impacts and approves Annual Product Quality Review reports
• Review and approves the protocol and the final report following any change to the manufacturing and/or formulation process
• Provide technical expertise and support for upcoming projects in the plant (commercial, R&D, etc).
• Provide support to answer questions from cross functional groups (e.g. Formulation, Master Group, Validation, R&D, Tech Transfer, QA, Production & Regulatory Affairs)
• Ensure the evaluation and training of employees
• Participate to other assigned tasks

Skills, Knowledge & Abilities:

• Excellent interpersonal and communication skills (written and oral), strong analytical skills, demonstrated ability to manage multiple/complex projects across different functions.
• Demonstrated leadership and organizational skills.
• Knowledge of dosage forms (solids, semi-solids, liquid dosages) and manufacturing and packaging processes;
• Ability to anticipate problems and propose solutions
• Experience with process improvement within a production environment
• Ability to work under pressure and set priorities;
• Possesses a positive approach to change and a demonstrated ability to take initiatives
• Experience writing investigation reports and process improvement protocols
• Experience writing pharmaceutical batch records
• Detailed knowledge of the pharmaceutical manufacturing process
• Be familiar with the various types of equipment used in the pharmaceutical industry
• Dynamic, self-sufficient
• Knowledge of CGMP\'s (good manufacturing practices)
• Excellent Knowledge of Windows environment and MS Office tools (Word, Excel, Powerpoint) as well as knowledge of TrackWise

Education : Bachelor
Bachelor

Experience : 7 years: 5 - 7 years relevant experience in the pharmaceutical domain in a production environment, technology transfer and/or process improvement. 2 - 4 years of supervisory experience

Pharmascience