Coordinator, Process PO5-BPO-PT B

The Coordinator, Process PO5 provides technical support and services to the process operations group with respect to the active pharmaceutical ingredient (API) plant equipment cleaning program. The coordinator is responsible for monitoring production equipment cleaning requirements, coordinating the timely issuance of equipment cleaning documentation and is a cleaning deviation lead investigator/Assignee.

• Responsible for the timely preparation of GMP documentation as required. This includes (but is not limited to) Change Control Requests, Cleaning Record update / preparations, supplemental instructions, validation cleaning documentation and standard operating procedures for cleaning of new equipment
• Coordination of production equipment cleaning documentation requirements; tracking of equipment and facility cleaning/status.
• Coordinates with Operations management, Production staff, Quality Control and Quality Assurance on scheduling priorities to meet production targets
• Accountable for GMP and drug regulatory guideline compliance within the Process Operations Group
• Set up and conduct chemical experiments, and analysis using NMR spectroscopy to determine the content and purity of sample during an equipment cleaning failure investigations.
• Ensure completion of documentation as required for GMP compliance, in coordination with Quality Assurance.Prepare solution or reagents, and operate laboratory equipment in the Process Operations department during an equipment cleaning failure investigations
• Compile experimental records and analytical results of cleaning failure investigations in a logbook
• Ensure cleaning records are issued to production in advance of their requirement.
• Monitors validation cleaning requirements; coordinates the communication of swabbing requirements; provides support toward cleaning validation activities as necessary.
• Cleaning deviation lead investigator/assignee; directs the improvement of cleaning procedures resulting from compiling and interpreting records of analytical studies.
• Maintenance & non-product residue cleaning failure deviation PR Assignee/lead investigator; coordinates the required child investigations, determines root cause and recommends meaningful CAPAs.
• Ensures suitable investigations have been completed before records for re-cleaning/verification /rinsing are issued.
• Designated trainer and subject matter expert for cleaning record issuance procedure and controls.
• Monitor cleaning documentation for improvements and coordinate change control efforts in collaboration with the Cleaning Validation Leader.
• Conducts on-the-floor monitoring of equipment cleaning in progress and provides guidance to production staff for safe execution cleaning records .
• Maintain laboratory equipment and apparatus in the Process Operations department, including verification/calibration of laboratory equipment, as per the daily/weekly/monthly/annual lab checklist requirements.
• Performs all work in compliance with our Code of Conduct and Business Ethics, and related policies and with the legal and regulatory requirements that apply to our job activities;
• Works in a safe manner collaborating as as a member to achieve all outcomes;
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
• Work with Process Designate to monitor batches including prelim cleaning , collect Time /Mass , Emissions , waste generated data and preparation of Batch Summary Tables etc
• All other relevant duties as assigned.

• Education
  • Graduate of three-year post secondary program from an accredited Institute
• Knowledge, Skills and Abilities
  • Excellent oral and written communication skills.
  • Ability to investigate and solve problems.
  • Ability to work independently and as a team member.
  • Proven computer skills; knowledge of Microsoft Office suite of programs and ability to learn/use new software as required.
• Experience
  • Two or more years’ experience working in GMP Production environment; solid knowledge of safety procedures, GMPs and SOPs.