About Apotex Inc.
Job Summary
The Senior Analyst is responsible for planning and monitoring of execution completion of LIMS related change controls within Apotex Corporate structure.
Maintenance of the Global laboratory documentation and data management systems, including the creation, revision and review of LIMS static data for RD and commercial products, and the assessment of all changes for impact to LIMS static data.
Act as a technical resource and responsible to escalate any critical issues identified during implementation and review of change controls pertaining to LIMS static data changes. Additional responsibilities include providing laboratory document LIMS data support and guidance to internal and external customers.
Responsible for product launch readiness and implementation of tech transfer packages for NPD, PLCM, MLCM and site transfers.
Job Responsibilities
- Create, revise and review specifications LIMS documents (CofA, Test Pro] and Analytical Test Methods for solid dosage, liquid dosage and raw material products in the corporate document management system in response to ongoing change control activities to support Global product transfers and apply harmonized testing policies for Apotex laboratories.
- Perform peer review of documentation and LIMS static data changes for accuracy and compliance with departmental, corporate and regulatory guidelines, and provide feedback as required.
- Issue document numbers for new specifications and analytical test methods.
- Route electronic documents through document management and laboratory information management systems to secure history
- Review new products and map testing requirements to existing analysis inventory list.
- Liaise with QC and RD labs, GIS, Global QC LIMS Business Support, Quality, internal external consultants on new developments cross-divisional changes for configuration, code, reports and projects.
- Evaluate and initiate change controls in support of the creation/revision of specification documents, methods, LIMS master data and LIMS code/configuration.
- Update appropriate corporate document management and change control systems to reflect revision history for new revised lab documents
- Ensure the timely posting of LIMS CofAs and Test Profiles to the corporate document collections to external customers as required.
- Develop maintain expert working knowledge of LIMS functionality through on-going project implementations.
- Coordinate tech transfers from RD to the commercial environment, including management of activities for the creation of Water-mark and release commercial specifications.
- Ensure timely publishing of all specifications once regulatory NOC approval has been received.
- Perform all work in compliance with current SODs, GSOPs GMPs.
- Support LIMS projects and initiatives. Represent RD and QC LIMS static data/document configuration at cross-functional LIMS meetings.
- Develop and maintain effective working relationships with internal and external customers.
- Manage hard copies of LIMS impact sheets, peer review forms and verification forms for timely storage and availability.
- Scheduling and monitoring of LIMS Review day to day activities.
- Work in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements
- Education
- Master s degree in Science
- Knowledge, Skills and Abilities:
- Experience with Microsoft Office applications. LIMS, Trackwise an added advantage.
- Knowledge of GMPs governing documentation in the pharmaceutical industry.
- SAP experiences an asset.
- Proficient in the use of Microsoft Office Suite applications.
- Demonstrated leadership skills.
- Demonstrated decision-making ability with strong problem-solving skills.
- Expert knowledge of all compendia process as it relates to publication and monitoring of changes in the USP, BP and EP.
- Strong knowledge of the ICH guidelines.
- Strong knowledge of regulatory guidelines for FDA and Health Canada.
- Ability to interpret and independently apply broad testing guidelines as per compendia (USP, BP and EP).
- Excellent organizational and interpersonal skills with a customer focus.
- Ability to coordinate and complete projects with strict deadlines.
- Demonstrated ability to work effectively in a team-based environment.
- Ability to adapt in a rapidly changing environment.
- Experience:
- Minimum 4-8 years in the pharmaceutical industry with an emphasis on Quality Control, Laboratory Information Management System (LIMS) and analytical data interpretation.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
