Specialist, QC Technology Transfer

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

Reporting to the Associate Director Quality Control this role will be involved in technology transfer method validation and method verification activities between Apotex and CMOs. The role will also lead and/or supports Out of Specification (OOS) Out of Trend (OOT) atypical result laboratory deviation and technical investigations related to technology transfer method validation method verification and confirmatory testing. Additionally will provide technical support and troubleshooting expertise for all associated testing and reviewing activities. This role will be required to liaise with relevant Apotex cross functional teams such as GEM QA and third-party customers to ensure seamless execution analytical technology transfer method validation and method verification activities. Reviews and approves protocols laboratory data and reports and decides on the course of action during investigation method validation/verification and analytical technology transfer as well as ensuring all supplies and required materials are available for the activities.

Job Responsibilities

• Collaborates closely with CMOs and contract laboratories to ensure analytical methods are scientifically sound validated verified transferred.
• Provides technical direction and support for troubleshooting problems with testing methods or instrumentation.
• Leads investigations in a highly technical and scientific environment overseeing investigative and experimental design directing the execution of experimental activities and ensuring all conclusions are scientifically sound regulatory compliant and defensible.
• Act as a manager in the absence of management during the shift (Prepares schedule and task assignments for the team and provides support to chemist).
• Liaises with various departments regarding issues to method challenges scheduling of priorities test failures deliverable dates of final reports change control and CAPA.
• Initiates reviews and/or approves QMS records including deviations OOS investigations CAPAs change controls and effectiveness checks as required.
• Approves and when necessary reviews the laboratory testing data prior to the release of raw materials for production or drug product as required.
• Participates in brainstorming to identify the root cause in product failures investigations and CAPA.
• Responsible for the quality of documentation and test results generated in the method verification validation and technology transfer.
• Creates reviews and approves various protocols and technical reports
• Facilitates the external testing of samples; evaluate and review external supplier results.
• Performs assessment on change control documents.
• Develops and maintains performance metrics and tracking systems to monitor team effectiveness productivity and achievement of operational objectives.
• Sets and monitors personal performance goals while providing input into departmental planning objectives and continuous improvement initiatives.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrates behaviours that exhibit our organizational values: Integrity Courage Teamwork and Innovation.
• 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.
• Other duties as assigned.

Job Requirements

• Education
  • Sc. degree from a recognized educational institute in Chemistry or a related science
• Knowledge Skills and Abilities
  • Excellent theoretical knowledge of analytical chemistry
  • Detailed knowledge of IR UV HPLC GCGCMS AA Auto Titrators Dissolution any Automated Instruments (i.e. Zymark) used in CLO Simple to Complex Wet Chemistry Techniques Trace Analysis to Macro Analysis Nasal spray testing techniques Cleaning Validation to Method Optimization Intra and Inter Technology Transfers
  • Strong organizational and interpersonal skills;
  • Strong leadership skills with a drive for results;
  • Excellent English oral and written communication skills;
  • Thorough understanding of GMP regulations
  • Flexibility and ability to work in a fast paced environment;
  • In depth understanding of compendia (USP BP EP) requirements regulations and standards for pharmaceutical testing.
• Experience
  • 7 years of progressive analytical laboratory/pharmaceutical industry experience with at least 2 years of experience as a senior chemist
  • 2 years of prior supervisory experience in an analytical laboratory in the pharmaceutical industry

At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

We offer 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.

The hiring range for this position is $83958 - $139930 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge skills and experience.
We are looking for top talent. If your qualifications differ from those listed above the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization you can excel based on our pay-for-performance philosophy. With comprehensive benefits a pension plan to help you save for retirement and learning and development opportunities we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.

Required Experience:

IC