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Pharmaceutical Manufacturing Specialist
2 months ago
About Us
Apotex Inc. is a leading global health company that produces high-quality, affordable medicines for patients worldwide.
We employ almost 7,200 people in manufacturing, R&D, and commercial operations, with medicines accessible to over 75 countries globally.
Job Overview
This role is responsible for executing all manufacturing activities within a team environment, ensuring compliance with Good Manufacturing Practice (GMP) and Standard Operating Procedures (SOPs).
The successful candidate will work independently and as part of a team to achieve daily compounding schedules, maintaining a safe and efficient working environment.
Key Responsibilities
- Compliance: Perform all duties according to SODs, GMPs, and established safety standards and company policies.
- Correctly complete all documentation as per SODs, GDP, and GMP requirements.
- Access Apotex intranet for locating and utilizing relevant SODs, MSDSs, company policies, and procedures.
- Notify Production Supervisor in case 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 to promote a culture of department compliance.
- Participate in incidents or non-conformance investigations to identify and correct root causes.
- Evaluate and implement new processes and technologies to improve efficiency and productivity.
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 units for start-up, shutdown, and demonstrate troubleshooting skills.
- Understand and 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.
- Identify and help eliminate potential barriers to reduce downtime.
- Ensure the proper selection, care, and use of tools, parts, and equipment while performing all job-related duties.
- Provide assistance to Senior team members, including set-up issues and investigations.
Teamwork:
- Show teamwork by assuming responsibility for team goal setting to contribute to the team's performance on a daily basis.
- Actively seek and accept positive and constructive feedback from Senior team members.
- Contribute to ongoing team growth and success in support of team and department goals.
- Communicate effectively both verbally and written, in English.
- Identify Continuous Improvement (CI) opportunities and implement action steps to optimize and improve efficiency rates, changeover times, and product quality for existing and new products.
- Capacity to effectively execute processes and participate 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 behaviors 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.
Requirements
- Education: Minimum High School diploma.
- Knowledge, Skills, and Abilities: Demonstrated ability to be a team player in a dynamic, fast-paced manufacturing environment. Demonstrated ability to utilize computerized/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.
Salary: $60,000 - $80,000 per annum, depending on experience.
