Associate, Production

Job Summary

The Associate, Production PO5 is responsible for the detailed review and verification of all in-house production documents to ensure completeness and accuracy. Responsible to ensure alignment of production practices with SOP and safety policy requirements.

Job Responsibilities

• Review executed process/production documentation (batch records (WBR), cleaning records (CR), and related forms and logbooks (inventory work sheets, raw material picklists, ECVRs, in-process test results, temperature and pressure charts) against current Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP) to ensure that records are complete
• Review Cleaning Records and Batch Records in a timely manner, and in support of the release and shipping schedule
• Assist Chemical Operators in the completion of their documents
• Collaborate with Chemical Operators to coach them on good documentation practices to drive continuous compliance improvements
• Report any documentation errors and deviations, including deviations discovered during documentation review
• Initiate and investigate deviations; track deviation trends and provide suggestions to improve overall productivity and increase compliance
• Work closely with Technology Operations and Engineering to increase simplicity and standardization of execution instructions and production equipment
• Collaborate with QA Auditors to reconcile deviations and documentation discrepancies
• Maintain and update relevant databases such as: emissions, equipment cleaning, SAP phase times
• Complete periodic SOP review; SOP (TBR) monitoring; official copy control
• Ensure that safety procedures are complementary to operational SOPs/instructions; report any discrepancies to your supervisor
• Production and Process logbook issuance/archiving/control
• Works 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
  • High school diploma
  • College diploma or University degree in Pharmaceutical Technology, Chemistry, Engineering (or related science) is an asset
• Knowledge, Skills and Abilities
  • Good command of the English language, both written and verbal;
  • Demonstrated ability to communicate in a clear and effective manner
  • Able to follow instructions according to written procedures
  • Proficient math skills and the understanding of significant figures and calculations
  • Working knowledge with MS Office, especially Word and Excel
  • Knowledge of industry Good Manufacturing Principles (GMP) and Good Docuemntation Prinicples (GDP) requirements is an asset
  • Time management, planning, prioritization, attention to detail
  • Demonstrated analytical and problem solving skills
• Experience
  • Minimum 2 years' experience working in an API environment
  • Experience in investigations is strongly preferred