QA - Document Control Assistant - Entry level (18 month contract)

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Title: Quality Assurance – DOCUMENT CONTROL ASSISTANT

Reports to: Supervisor R&D Quality Assurance

This position is responsible for administering the processes and practices which support documentations compliances. The candidate will work in a R&D pharmaceutical facility and in close collaboration with Quality Assurance, with a key-focus on documentation accuracy, quality and integrity.

The successful candidate will develop strategies for SOP development, oversee systems for document issuance, reconciliation and archival as well as work on an effective training program to support GxP operations and will assist in the day to day record management activities within Biolab Pharma Canada complying with company regulatory requirements.
This position also will track and monitor the status of all issued documentation and support with record issuance, formatting and reconciliation, while working closely with the Calibration, Analytical Development and Formulation Development teams.
This position performs GMP documentation activities required to meet company’s goals and objectives in a timely manner while complying with departmental SOP’s and guidelines set out by the regulatory agencies, ANVISA and ICH (international Conference on Harmonization) and should be a quality focused individual, have strong knowledge and experience in Microsoft Office as well as experience in pharmaceutical regulations environment.

Key job responsibilities and duties:
Responsible for document filing and maintenance
Facilitates the full life cycle of master documents (including but not limited to SOPs, Batch Records, Test methods, Protocols, Reports, and Specifications etc).
Facilitate the filing, tracking and archival of GMP documentation records
Maintains database used for tracing various GMP documentations.
Will work directly with QA department and other departments to revise issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
Assists in following up with training records.
Prepare and inspect documents for scanning operations, scans and re-assembles documents.
Authors documents, templates, forms to support activities within the Research and Development department.
Helps in drafting, formalizing of SOPs, forms and required GMP documents
Format master documents, distributions and archiving.
Ensures records are maintained according to regulatory requirements.
Ensure basic grammatical accuracy and completeness when revising documents.

Education and experience requirements:
Canadian equivalent to Bachelor of Science degree or higher degree, preferably in Pharmacy, Chemistry or Pharmaceutical Chemistry. Diploma/Degree/Certificate in Quality Assurance is preferred.
One to two years of relevant hands on pharmaceutical experience. Knowledge and experience of quality management systems in product development. Direct knowledge of manufacturing processes and/or analytical techniques requirements is preferred.
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Access) and Adobe Acrobat Professional
Demonstrated ability to work independently or as a part of a team
Highly motivated and have the skills to handle multiple projects and prioritize the work.
Excellent communication skills (oral and written) and interpersonal skills are required with the ability to explain complex concepts with clarity and simplicity.

Job Types: Full-time, Fixed term contract
Contract length: 18 months

Benefits:

• Casual dress
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Flexible schedule
• Life insurance
• On-site parking
• Paid time off
• Vision care

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• No weekends

COVID-19 considerations:
We follow all COVID19 Guidelines set by Peel Public Health

Application question(s):

• currently Resides in GTA

Education:

• Bachelor’s Degree (preferred)

Experience:

• relevant Canadian Pharmaceutical: 1 year (required)

Language:

• English (preferred)

Application deadline: 2022-03-25
Expected start date: 2022-04-18