Specialist, QC Technology Transfer

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, GC,GCMS, 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