R&d Data Reviewer

2 weeks ago

Mississauga, Canada Biolab Pharma Ltd Full time

**Key job responsibilities and duties**:

- Perform activities in the analytical development area to support the development of new products and analyticalmethodologies per departmental SOP’s and ICH guidelines.
- Review analytical data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions, or defects to comply with cGMP.
- Review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficientmanner to ensure quality and efficacy of the product.
- Review analytical data associated with the development, transfer, or validation of robust, sound analytical methods.
- Review test methods, validation protocols and reports as applicable.
- Perform peer review of notebook and data generated by other personnel in the analytical development laboratory.
- Review data related to the qualification, maintenance and calibration of R&D analytical development equipment
- Support the preparation of submission documentation
- Identify and make recommendations for improvements to ensure continuous improvement.
- Ensure all analytical and other lab activities are carried out in compliance with the required standards conforming tocompany’s policies, cGxP, SOPs, regulatory regulations and guidelines, and safety and environmental guidelines.
- Support internal projects and external Contract Manufacturing Organization projects in alignment with Biolab’s objectives and initiatives.
- Take part in /lead Laboratory Investigations and change controls.
- Assist in the preparation for internal/regulatory inspections

**Education and experience requirements**:

- Canadian equivalent to Master of Science or Bachelor of Science degree, preferably in Pharmacy, Chemistry, or Pharmaceutical Chemistry or related scientific discipline required.
- More than two years of relevant hands on pharmaceutical experience in product development. Demonstrates knowledge and experience of analytical chemistry by successfully operating analytical instrumentation such as HPLC, UV/Vis, GC, dissolution apparatus. Understanding of the principles used in DOE, risk based assessment tools, quality by design,method validation, equipment troubleshooting and technical transfer. Experience with Chromeleon software is preferred.
- 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

**Salary**: Up to $65,000.00 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
- Tuition reimbursement
- Vision care

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

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