Compliance Associate

  Compliance Associate – Quality Systems 

22 Months Contract Role

Job Type: Current vacancy 

WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.

For more than 30 years CPL has partnered with the world's leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.

We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee's assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

Job Summary:

The role is responsible for completing Annual Product Reviews (APRs) and addressing any out-of­trend findings in collaboration with internal SMEs and customers. Supports key regulatory activities, including FDA and Health Canada submissions, drug listings, and annual renewals, while providing training in systems such as TrackWise and SuccessFactors. Support Regulatory Inspections and Client Audits as the subject matter expert for the Annual Product Review process and procedure. Contributes to audits and internal compliance efforts.

JOB RESPONSIBILITIES: 

• Complete Annual Product Reviews as defined by the CPL APR schedule and procedure
• Investigate, manage, and actively resolve APR out of trend issues in conjunction with CPL's Subject Matter Experts (SME) and customer.
• Provides training to other employees within the company in areas that he/she has the qualification.
• Ensure timely Regulatory activities such as:
  • FDA Establishment Registration for Danbro & Meadowpine
  • Generic Drug User Fee Amendments (GDUFA) - Self Identification
  • CARES Report Submission
  • Drug Listing of new commercial products for US Market
  • Delisting of discontinued products for US Market
  • Annual Blanket No Change Submission for US Product Over-the-Counter
  • Monograph Drug User Fee Program (OMUFA)
  • Annual License Renewal (ALR) - Health Canada
  • Natural Health Product Site Licence Renewal - Health Canada
  • Plastibase 50W DMF
• Participates in regulatory agencies and customer audits and the
• subsequent corrective action completion, as required.
• Participates in internal audit program to ensure compliance with GMP and other
• regulatory requirements, when required.
• Backup to the issuance of logbook for manufacturing site.
• Provide TrackWise Change Control training, when required
• Backup for Success Factor, performing tasks such as update ADP for new employees, assign/update curricula for new/existing employees, circulate SOPs for training, make new or updated SOPs/WI effective, implement change control in TrackWise, generate training records of employees for Audit whenever required.
• Responsible for promoting and maintaining safe and healthy working conditions in his/he assigned working
• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Education:

• Bachelor of Science degree in an applicable Scientific discipline.

Experience:

• A minimum of 3-4 years of pharmaceutical manufacturing experience including experience in performing investigations / root cause analysis.

Knowledge, Skills, Abilities:

• Knowledge of cGMP requirements for pharmaceutical manufacturing.
• Knowledge of computer systems such as SAP and Microsoft Office Excel.
• Excellent verbal and written English communication skills. Ability to effectively communicate to multi levels in the organization including management specifically on the risks and benefits of decisions impacting site compliance.
• High attention to detail in reviewing documents for accuracy and compliance to specifications.
• Demonstrated competencies in CPL's core values of Excellence, Rigor, Ownership, Integrity,
• Agility
• Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.

PHYSICAL DEMANDS/WORKING CONDITIONS:

• General office environment.
• Some flexibility in work schedule to support audits and ensure deadlines / timelines can be met.

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 polices, please contact us at  

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.