Chemist, Process Ops PO7-BPO-PT B
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Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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Job Summary
The Chemist Process Operations PO7ensures the safe and effective implementation and scale-up of process technologies complying with GMP and drug regulatory guidelines at Apotex Pharmachem Inc. The areas of responsibility include process characterisation and mapping process implementation process costing root cause analysis and CAPA determination process technology optimisation and scale-up.
Job Responsibilities
- Accountable for the safe and effective implementation scale-up and operational optimisation of process technologies at Apotex Pharmachem Inc.
- Accountable for GMP and drug regulatory guideline compliance within the Process Operations Group throughout the implementation and commercialization of process technologies.
- Independently develops safe and effective implementation and scale-up plans of API manufacturing processes to achieve optimal process fit to pilot/production facility through detailed process mapping. Coordinate efforts of process implementation programs with R&D and RA/QA.
- Responsible for the timely preparation of GMP documentation as required. This includes (but is not limited to) Change Control Requests Master Batch Records supplemental batch instructions deviation reports validation documentation annual product reviews standard operating procedures DMF supporting documentation.
- Prepares associated process documentation and provides to Production and Materials Management staff for batch execution. Ensure completion of process documentation as required for GMP compliance in coordination with Quality Assurance.
- Ensures the completion the Process Operations component of HAZOP reports and coordinates with R&D and Engineering on the overall completion of HAZOP reports for new and existing processes.
- Responsible for real time completion of batch summary tables and process trending for pilot and commercial processes.
- Completes Corrective Actions and Preventative Actions investigations and ensures that the identified root cause and follow-up actions are appropriate and effective.
- Complete campaign summaries and evaluate campaign success with respect to campaign goals. Complete up-to-date costing analyses of assigned processes and critically evaluate production costs; identifies methods for cost reduction.
- Coordinates with Operations management Production staff Quality Control and Quality Assurance on scheduling priorities to meet production targets.
- Conducts on-the-floor monitoring of production in progress and provides guidance to production staff in the execution of pilot and commercial manufacturing processes. Conducts in-process testing as required.
- Troubleshoot problems encountered during new process piloting or routine production and design experiments with R&D as necessary to investigate and resolve process related challenges.
- Systematically evaluate process performance data from batch records concurrently with batch production develop and implement procedures to ensure consistent performance and identifies opportunities for improvement while complying with GMP and drug regulatory guidelines.
- Participate as required in the transfer of process technologies to contract manufacturing sites for assigned processes.
- 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
- Bachelor degree in Chemistry or chemical engineering from a recognized academic institution
- Knowledge Skills and Abilities
- Proven computer literacy particularly with the Microsoft Office suite of programs
- Proven problem solving and trouble shooting skills
- Ability to work independently and as a team member with demonstrated leadership skills.
- Excellent oral and written communication skills.
- Self-motivated driven individual who is a results-oriented team player with effective interpersonal skills
- Experience
- Minimum 3 years experience as process chemist in a cGMP Active Pharmaceutical Ingredient (API) facility
At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing please advise us if you require an accommodation.
Key Skills
- B2B Sales
- Customer Service
- Communication skills
- Outbound Sales
- Account Management
- Upselling
- Customer Support
- Data Mining
- 3G
- Human Resources
- Internet Of Things
- 4G/LTE
About Company
Apotex is the largest Canadian-owned pharmaceutical company providing patients around the globe with quality, affordable medicines. We are an innovative global research and technology leader in generic pharmaceuticals that serves customers and partners in the U.S. market, as well as 1 ... View more
