Spécialiste aseptique

Schedule: 3:00 pm until 11:00 pm, flexible (37.5h/week)

Would you like to make a difference by putting your talent at the service of human health? A healthier world starts with you You are the crucial link between our medicines and our patients. Choosing Pharmascience also means choosing yourself, because we place human health, including yours, at the heart of our mission, and your personal and professional achievements are at the forefront of our concerns. Being able to grow means working with a Canadian leader in the generic pharmaceutical industry.

Benefits of working at Pharmascience:

Evening shift premium Annual performance bonus Internal referral program of up to $3,000 Vacation and floating vacations upon hiring Group insurance coverage as of day 1, including telemedicine Competitive pension plan with employer contribution as of day 1 Employee assistance program Ongoing training offered Stimulating and collaborative work environment On-site parking Gym

Reporting to the Microbiology Manager, you will be responsible for ensuring the compliance of aseptic activities, as well as the compliance of manufacturing operations. You will also be responsible for ensuring the smooth running of the media fills.

Responsibilities:

Compliance of aseptic activities

Perform audits / assessments of aseptic areas and personnel on his shift; Training and evaluation of staff for dressing and working in aseptic areas; Make recommendations for improvement in aseptic areas. Member of the aseptic committee

Compliance of manufacturing operations

Collaborate with the production department; ensure compliance with and application of quality procedures and systems; Support the production department when discovering an operational issue; Suggest immediate corrective actions to ensure compliance of operations; Support other departments in projects or initiatives affecting operations and the aseptic environment (engineering projects, smoke tests, technical shutdowns, remediation, etc.) and ensure compliance with applicable regulations, etc. Support the environmental monitoring program including trend reports

Media Fill Program

Support the Media Fills program on his shift, by closely monitoring activities with the production and microbiology group; Observe filtration and filling activities and initiate notices of non-compliance following the observation of non-compliant aseptic techniques; Supervise the reconciliation steps of the Media Fills.

Skills, knowledge and abilities:

Good knowledge of working in aseptic areas Experience in the production of injectable products (an asset) Knowledge of GMPs Good communication and comprehension skills in French (oral and written) Attention to detail and a job well done Good teamwork skills

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