R&D Quality Assurance

Title: R&D QUALITY – DOCUMENT CONTROL ASSISTANT

Reports to: R&D Quality Assurance and Technical Documentation Manager

The Quality – Document Control works under the guidance of QA Associates and QA Manager. 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 document control, 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 a regulated pharmaceutical 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.

· Ensure 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

· Prior experience with electronic quality management systems

· 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, Permanent

Pay: Up to $41,000.00 per year

Benefits:

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

Application question(s):

• currently Resides in GTA

Education:

• Bachelor's Degree (preferred)

Experience:

• relevant hands-on Canadian Pharmaceutical: 1 year (required)

Language:

• English (required)

Work Location: In person