Job Description

Position description

Job Title

Stability & Analytical Services Data Reviewer

Company Details

Septodont is a leading manufacturer of dental pharmaceuticals and medical devices. The French-based company employs over 1,800 people globally. We have six manufacturing plants in France, India, North and South America, and an international distribution network that is dedicated to serving the needs of dental professionals in more than 150 countries. Our North American operations has facilities in Ontario, Montreal, and Pennsylvania. It also has Latin American operations with facilities in Brazil and Colombia.

Job Summary

The Stability and Analytical Services (SAS) Data Reviewer position is accountable to the SAS Supervisor and is responsible for performing various tasks in support of the day-to-day operation of the Stability and Analytical Services department. These tasks include the review of data generated by the chemists when testing raw materials, components, finished products, in-process, process validation, stability samples, reviewing technical documents and providing feedback

Responsibilities

• Reviewing raw data, laboratory notebooks and logbooks for all the tests performed on raw materials, components, bulk, finished products and stability samples in a timely manner
• Reviewing accuracy of data entries on specifications and in LIMS system prior to the release of the C of A
• Ensuring the correct revision of the test method/SOP/Compendia/Test template form is used for the analysis and documented in the laboratory notebook
• Cross-checking the expiry date of reagents, reference standards and test solutions
• Checking the calibration due dates and instrument usage logbooks
• Ensuring the correct formulas were used to generate accurate results
• Providing supports to management by reviewing protocols, specifications, reports, test methods and SOPs for accuracy and to ensure they comply with the established guidelines and in-house standards
• Ensuring compliance with cGMP/cGLP and good documentation procedure during the review process
• Reviewing software audit trail to ensure data integrity is maintained
• Reporting out of specification (OOS) results and/or any deviations to the management
• Supporting OOS investigation and regulatory audits if required
• Communicating with the manager, supervisor and chemists regarding any quality concerns
• Supporting and mentoring laboratory staff in the daily laboratory documentation
• Observing and supporting all safety guidelines and regulations using SDS, performing 5S and maintaining audit readiness of responsible work areas
• Demonstrating the Company Mission, Vision and Values Statement, policies, and current standard business practices
• Other related duties as assigned

Qualifications

Education

• B.Sc. in Chemistry, Biology, Biochemistry, Pharmaceutical Science, or university degree in a related field

Skills and Experience

• Minimum of 4-5 years of laboratory experience coupled with 1 to 2 years of peer review of lab data
• Advanced understanding of the methodology and operation of lab instruments
• Familiarity with laboratory software such as Empower, Chromeleon, Lab X, Spectrum 10 ES, ICP Expert, TestLoop and LIMS
• Proven track record in reviewing scientific documents to GMP standard
• Sound knowledge of regulatory guidelines (e.g. USP, EP, BP and ICH)
• Good understanding of data integrity concept
• Acute attention to detail
• Well-developed time management skills with the ability to manage multiple priorities
• Ability to work in a self-directed team environment
• Familiarity with Microsoft Office applications, especially Excel, Word and Power Point presentation

Contract type

Permanent

Candidate criteria

Minimum level of education required

3- Bachelor

Minimum level of experience required

2-5 years

Languages

English (3- Advanced)