R&d Data Reviewer - Mississauga, Canada - Biolab Pharma Ltd

Biolab Pharma Ltd

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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, inprocess 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: