Our people make the difference

Special Projects Lead, QC Analytical Operations

Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.

Purpose:

To provide scientific direction that will ensure laboratory activities related to analytical method development, method transfer/verification and validation meet regulatory requirements and priorities align with Lean objectives; share technical expertise with QC analysts; conduct complex testing, analytical investigations and troubleshooting at expert level.


SPECIFIC RESPONSIBILITIES:

  • Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
  • Conducts complex testing at expert level.
  • Coaches technical staff and provides adequate instructions and to ensure project execution is complete, correct and on time.
  • Investigates failures and deviations to determine root cause and implements effective corrective and preventive actions.
  • Facilitates the resolution of technical problems to mitigate any impact on timely delivery of quality results.
  • Keeps current on emerging analytical technologies, and provides technical resource to Analytical Projects strategies.
  • Assesses possible alternatives and provides recommendations when new or alternate technologies are considered or mandated.
  • Participates in the technical training and development of others.
  • Evaluates prospective Projects, analytical methods, literature, procedures and protocols to determine technical feasibility and project scope.
  • Reviews the compilation, evaluation, interpretation and reporting of experimental results to ensure the objectives of each project are met.
  • Performs testing, interprets and documents all test results, calculations, observations and completes report summaries strictly adhering to SOPs and cGMP/GLP standards.
  • Ensures that all regulated activities in the area of responsibility are adequately described in written procedures and protocols and that the work is performed and documented according to the written procedures and the regulations.
  • Reports analytical results adhering to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate), data integrity requirements and is responsible for the procedural integrity of all work performed.
  • Determines timelines and negotiates resource requirements with QC management to ensure timely work completion.
  • Consults all relevant internal stakeholders to ensure project strategy is scientifically sound, technically feasible and in compliance with SOPs, regulatory guidelines, GMPs prior to committing an approach to the client.
  • Ensures relevant activities are coordinated with Analytical Teams, Data Review, Microbiology, Account Managers, Purchasing and Quality Assurance to optimize project delivery according to Customer expectations.
  • Responsible for the efficient utilization of resources and supplies to reduce waste.
  • Supports Lean initiative and Continuous Improvement projects in the QC Laboratory to enhance testing turnaround time and right first time via robust methods, effective CAPA, method optimizations, etc.
  • Participates in the creation and implementation of strategies to measure, standardize and improve aspects of QC Analytical Operations.
  • Responsible for disposing waste in a safe manner and maintaining cleanliness of the lab.
  • Performs other related duties as assigned.
QUALIFICATIONS:
  • M.Sc. or Ph.D. in analytical chemistry, pharmaceutical sciences or other related field with 3-5 years of related experience or B.Sc. with 5-10 years of related experience.
  • Elemental impurities ICH Q3D, USP <233>, and ICP-MS Knowledge.
  • Expert level knowledge of analytical method development and validation and troubleshooting analytical problems.
  • Proficient in root cause problem solving of analytical issues; demonstrated effective CAPA.
  • Working knowledge of current regulatory and pharmacopoeial requirements for testing of pharmaceutical materials and products.
  • Excellent verbal and written communication skills and report writing skill.
  • Working knowledge of Excel and Word.
  • Ability to work independently and as part of a team.
  • Effective coaching skills with a proven ability to motivate team members and facilitate individual work styles.
  • Strong work ethics, close attention to detail, time management, organizational skills, problem solving and continuous improvement focus, and ability to multitask.
  • Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
  • Exceptional customer focus and demonstrated adherence to CPL’s core values of Integrity, Respect, Trust and Fairness.
PHYSICAL DEMANDS AND WORKING CONDITIONS:

  • Laboratory and office work conditions including work with computers. Lab presence requires use of protective equipment, such as safety glasses, lab coat and appropriate footwear, to reduce personal exposure and injury.
  • Reaching and bending and light lifting on a daily basis when preparing reagents, solutions, samples.
  • Flexibility in hours of work to address emergency issues outside of normal workday.

CPL is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals.  CPL is committed to accommodating persons with disabilities.  If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at hr@cplltd.com


Interested applicants should submit a cover letter and resume to the contact information below. If submitting your application via e-mail, please indicate the job title in the subject line.

Contract Pharmaceuticals Limited Canada
Human Resources
F) (905)821-0386
E) hr@cplltd.com
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We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.