Manufactures product as per patient, customer and company requirements while working within a team environment. Responsible and accountable for executing all manufacturing activities of the Batch Manufacturing Records (BMaRs), manual and automated Clean in Place process and Steam in Place process. Perform manual cleaning of all compounding equipment and manufacturing rooms as per associated standard operating procedures. Implement all department requirements as directed by the Dept. Supervisors, while following all S.W.P, G.M.P.’s, S.O.D.’s and Company policies/ regulations and remains aligned to the Apotex Strategic Objectives.

Understanding of Good Manufacturing Practice and Standard Operating Procedures. Possess multi-tasking skills to achieve daily compounding schedule. Must be able to work independently as well as in a team environment. Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion; Demonstrates strong and visible support of our values.

Job Responsibilities

Compliance:

• Perform all duties according to the SODs, GMPs and all other established safety standards and company policies
• Correctly complete all documentation as per SODs, GDP and GMP requirements
• Access Apotex intranet for the purpose of locating and utilizing relevant SODs, MSDSs, company policies and procedures
• Notify Production Supervisor in the event of a departure from procedure, product defect, safety incident or other non-conformance event observed
• Recommends amendments to existing SODs for improvements
• Participate in audits in order to promote a culture of department compliance
• Participate in incidents or non-conformance investigations to identify and correct root causes
• Ensure that company policies and regulations/procedures with respect to safety/quality compliance are implemented and followed

Productivity and Equipment:

• Safely operate all required equipment and machinery including those used to manufacture, store, clean and transport production related assets
• Effectively process batches within specifications to meet department batch execution targets by ensuring optimal cycle time in support of schedule adherence Dismantle, clean, sanitize and assemble processing equipment according to established SODs to ensure GMP compliance and meet department changeover targets in support of reliability and productivity goals
• Prepare and control process unit for start-up, shutdown and demonstrates troubleshooting skills. Ability to adjust equipment, valves, pumps and process equipment for maintenance.
• Understands, operate automated systems (Clean In Place & Steam In Place) with the use of Human Machine Interface/Computerised control panels as per applicable procedures.
• Execute applicable SAP transactions accurately and in a timely manner.
• Identifies and helps eliminate potential barriers in an effort to reduce downtime
• Ensure the proper selection, care and use of tools, parts and equipment while performing all job related duties
• Provides assistance to Senior team members including set-up issues and investigations
• Provide process feedback to Technical Operations with respect to new products or current product improvements

Teamwork:

• Show team work by assuming responsibility for team goal setting to contribute to team’s performance on a daily basis
• Actively seek and accept positive and constructive feedback from Senior team members
• Contribute to on-going team growth and success in support of team and department goals
• Communicate effectively both verbally and written, in English
• Identify Continuous Improvement (CI) and helps implement action steps to optimize and improve efficiency rates, changeover times and product quality for existing and new products
• Capacity to effectively execute processParticipate in department projects or initiatives and actively contributes in team meetings and other team-related activities by providing positive feedback for process improvement

• Work 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
  • Minimum High School diploma.
• Knowledge, Skills and Abilities
  • Demonstrated ability to be a team player in a dynamic, fast phased manufacturing environment.
  • Demonstrated ability to utilize computerised /automated systems, computer software packages including e-mail, Excel, Word
  • Possess strong mechanical aptitude.
  • Demonstrated ability to facilitate the exchange of information among the team during bulk manufacturing.
  • Strong two way communication and listening skills.
  • Understanding of cGMP and ability to work in accordance with all departmental requirements.
  • Able to lift between 5 to 20 kg and must be able to bend, reach, push/pull mobile equipment, bulk tank for duration of shift.
• Experience
  • Experience in the pharmaceutical manufacturing environment executing manufacturing instructions and using automated Clean In Place & Steam In Place systems is preferred.