Document Control Administrator responsible for maintaining policies and procedures at pharmaceutical sites. Overseeing document management, compliance initiatives, and quality standards.
Responsibilities
Creates and revises SOPs and controlled forms (ACF/REF) as required by approved change requests.
Maintains revision records for changes and completes within required time frame.
Creates and revises Master Batch Production Record (MBPR) documents for commercial products based on approved requests.
Maintains revision records for changes to products.
Creates product and raw material analytical report and certificate of analysis templates.
Assists in maintaining MBPR packages and ensures all are up to date and ready according to planning schedule.
Keeps appropriate records archived for required retention time.
Provides support and assumes delegated responsibilities for compliance-related programs and initiatives as assigned by the Director.
Achieves Required Results in productivity, quality and services as defined through key performance indicators for the department.
Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
Performs other duties as required.
Requirements
High School Diploma, GED/CAEC and/or educational credential assessment (ECA) is required, College Diploma and/or bachelor’s degree in business administration or related field preferred.
1+ years of experience in information/document management or related field is preferred.
Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word).
Accuracy and attention to detail while working under tight deadlines.
Effective communication skills with individuals at all levels of the organization.
Resourceful, innovative, and able to work independently.
Flexibility to shift priorities quickly and effectively manages simultaneous requirements.
Benefits
Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.
Employee Reward & Recognition programs.
Opportunities for professional and personal development & growth including tuition reimbursement.
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