Pharmaceutical Data Reviewer Analytical Development

6 months ago

Mississauga, Canada Biolab Pharma Ltd Full time

**JOB OPPORTUNITY**
**Title: DATA REVIEWER ANALYTICAL DEVELOPMENT R&D**
**Reports to: R&D QA & Technical Documentation Manager**

The Analytical Development data reviewer assists and supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. Responsible and accountable for independently reviewing all data associated with developing, transferring, verifying or validating analytical test methods; for reviewing all data associated with chemical and physical laboratory tests on raw materials and R&D samples: in-process, finished product, stability, Preformulation, etc., required during product development and/or to release GMP supplies intended for formal stability studies and/or clinical studies.

**Key job responsibilities and duties**:

- Perform activities in the analytical development area to support the development of new products and analytical methodologies 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 & efficient manner 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 to company’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

Pay: 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 (required)

**Experience**:

- Pharmaceutical Analytical Development: 3 years (required)

**Location**:

- Mississauga, ON L4W 0B3 (preferred)

Work Location: In person

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