Pharmascience Inc

Senior Equipment and System Validation Specialist - 12 months contract

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    Pharmascience Inc

    Senior Equipment and System Validation Specialist - 12 months contract

    Pharmascience Inc Montréal, Quebec

    Engineering and science
    Reference : 2018-4245
    Posted 18 day(s) ago | Still Open
    Contract / Freelance Full time As soon as possible

    DESCRIPTION

    The Senior Equipment and Systems Validation Specialist participates in the validation of complex equipment/systems at the Royalmount site.

    As a senior team member, He or she acts as a validation project manager and ensures that all stages of the project are followed in accordance with standard procedures (health and safety, Good Manufacturing Practices, etc.). He or she coordinates activities of all involved parties: professionals, entrepreneurs, consultants, regulatory bodies, as well as acting as a liaison to internal clients.

    He or she reviews and approves the documents (protocols and reports) from the Validation Specialists.

    Responsibilities:
    • Write validation protocols – installation, operational and performance qualification
    • Execute or supervise the execution of the protocol tests
    • Manage the revision and approval of protocols
    • Manage the documentation related to validation activities (filing, update and preparation)
    • Participate in the resolution of deviations and deficiencies
    • Participate in change control evaluations and updates for validated systems
    • Participates in audits as a validation expert
    • Participate in regular meetings with the validation team
    • Help/support the documentation team for the writing of SOPs

    Working conditions:
    • Will work in an office as well as in the production facility
    • May be required to travel to different production sites

    Education and Training :
    • Bachelor of Engineering (Chemical or Mechanical) OR of Sciences (Chemistry, Bio-chemistry, Biology)

    Experience :
    • Minimum 7 years’ experience in the Pharmaceutical industry.
    • Minimum 5 years’ experience in qualifying equipment used in manufacturing and/or packaging of various pharmaceutical forms, as well as critical systems (HVAC, purified water, compressed air)
    • Capacity to develop all documents required for 21 CFR part 11 compliance, including URS, validation plans, qualification protocols and summary reports
    • Knowledgeable in automated and computerized systems qualification
    • In-depth knowledge of the cGMP’s and regulatory requirements for equipment and system validation/qualification (FDA an asset)
    • Project management experience (an asset)

    Skills, Knowledge and Abilities :
    • Fluent in English and French (spoken and written)
    • Capacity to manage multiple projects simultaneously
    • Capacity to review and approve technical reports efficiently
    • Capacity to write technical reports in a neat and concise manner
    • Ease in managing pressure and adapting to change
    • Possess a good sense of communications and urgency (prioritization)
    • Enjoys teamwork and exchanges
    • Capabilities in software tools such as Microsoft Office, Outlook.

    Pharmascience subscribes to employment equity principles for women, visible minorities, individuals with disabilities and aboriginal people.
    Pharmascience Inc

    Pharmascience Inc

    Chef de file en matière de fabrication de médicaments génériques, nous concevons et distribuons aussi des médicaments brevetés ainsi que des médicaments vendus sans ordonnance. Basé à Montréal, au Canada, nous comptons plus de 1500 employés....

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