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, …
Skills: Manufacturing Science and Technology, Technology Transfer, Process Validation, Cleaning Validation, GMP Compliance
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, …
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, …
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, …
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, …
Executive - Documentation - Production Operations Support
Anekal, Karnataka, India · On-site
Mid level$862M raised
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, …
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, …
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, …
Acerca de Apotex Inc. Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un a…
Skills: SAP R3, Inventory Control, GMP Compliance, Budget Management, Document Control
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, …
Skills: Project Management, Data Analysis, Financial Reporting, Master Data Management, SharePoint
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, …
Skills: Technical writing, Document management, Microsoft Office, GMP compliance, Change control
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, …
Skills: Material handling, Warehouse operations, SAP, Logistics, Order picking
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, …
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, …
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, …
Scientific Leader, Analytical Product Life Cycle Mgmt/Method Life Cycle Mgmt
Toronto, Ontario, Canada · On-site
$83k–$116k/yr
Senior+$862M raised
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, …
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, …
Acerca de Apotex Inc. Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un a…
Acerca de Apotex Inc. Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un a…
Acerca de Apotex Inc. Apotex es una empresa global de salud con sede en Canadá. Mejoramos el acceso diario a medicamentos y productos de salud asequibles e innovadores para millones de personas en todo el mundo, con un a…
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Full-time
postgraduate degree
Posted 1d ago
Apply by Oct 30
~40 hrs/week
Responsibilities
The Executive is responsible for overseeing process optimization, technology transfer, and validation activities in compliance with global regulatory guidelines. They will supervise personnel, manage project prioritization, and provide technical support for manufacturing processes and site transfers.
Requirements
Candidates must hold a Master's degree in Pharmacy (Pharmaceutics) and possess 3 to 7 years of experience in MS&T. Essential skills include knowledge of solid dosage forms, process validation, and regulatory requirements for markets such as the USA, Europe, and Canada.
Full job description
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.
Exective is responsible for overseeing all process optimisation, Trail & validation activities in compliance with GMP, SOPs, and global regulatory guidelines (Health Canada, FDA, EU). The role includes supervision, training, and development of personnel involved in execution and protocol & report preparation, with accountability for work scheduling, project prioritization, and timely resolution of roadblocks.
Job Responsibilities
Site technology Transfer:
Prepare, review, and update standard operating procedures and Validation Master Plan.
Coordinate and review quality risk management (QRM).
Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
Cleaning validation related activities and e-Residue software application activities.
Prepare and review PDE changes.
Prepare and review of quarterly and annual monitoring reports for cleaning validation.
Prepare for regulatory audits and ensure compliance.
Prepare and review Annual Product Quality Review (APQR) and data trending for products (3B).
Review and approve process validation protocols and reports for demonstration, optimization, qualification, and verification batches.
Prepare and review process validation and APQR activities in QMS Track wise.
Conduct QA assessments for change control, action items, and review MDoc from various departments in QMS Track wise.
Coordinate periodic self-inspection activities.
Review of Technical data package for site transfer products.
Review of tooling drawings of site transfer products.
Provide support for manufacturing license application of site transfer products.
Preparation of following technical documents with respect to site transfer:
Cross contamination quality risk assessment report for new product introduction at ARPL.
Master Formula Records
Technical Risk Evaluation of Products transferred from Apotex manufacturing sites to Apotex research private limited (ARPL), India
Process Optimization Protocols & Reports
Process Demonstration Protocols & Reports
Hold Study Protocols & Reports If any
Placebo Formulation sheets
Technical Risk Assessment
PPQ Protocols & Reports
CPV Protocols & Reports
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Ensure archival of Process Optimization/Placebo batch documents to QA.
Any other activities as assigned related to site technology transfer.
Technology transfer of New products:
Preparation of the following technical documents with respect to Technology transfer of new products
Cross contamination quality risk assessment report for New product introduction at ARPL.
Master Formula Records
Technical Risk Evaluation of new products
Process Optimization Protocols & Reports
Process Demonstration Protocols & Reports
Hold Study Protocols & Reports If any
Placebo Formulation sheets
Technical Risk Assessment
PPQ Protocols & Reports
Nitrosamine Risk Assessment Report
CPV Protocols & Reports
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Any other activities as assigned related to New product launch.
Manufacturing process support:
Troubleshooting of processing issues for commercial batch manufacturing at shop floor.
Manufacturing process support in the event of any issues which are unplanned and require immediate resolution.
Draft technical summaries, investigation reports, or SME responses following QMS Track Wise Investigation procedures.
Job Requirements
Education:
Minimum Master Degree in Pharmacy (Pharmaceutics)
Knowledge, skills and abilities :
Should have knowledge of process development, MS&T and Technology transfer on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential.
Should have a good understanding of Product development process along with scale-up knowledge of the product and Process Validation.
Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet
Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
The willingness to upgrade knowledge/education on an on-going basis.
Experience
Minimum 3 to 7 years of Experience in the MS&T
At Apotex, we are committed to fostering a welcoming andaccessible 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.
At Apotex, we are a global team empowering everyone to achieve better health. We improve everyday access to affordable, innovative medicines and health products for people around the world, with a portfolio comprising more than 550 generic, biosimilar, and innovative medicines, along with more than 225 natural health products. Headquartered in Toronto, we are the largest Canadian-based pharmaceutical company and a health partner of choice in the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.
To report an Adverse Reaction/Experience to Apotex, or an Apotex affiliated company, please contact: [email protected].
Offices: 150 Signet Drive, Toronto, Ontario M9L1T9, CA · 50 Steinway Boulevard, Etobicoke, Ontario M9W 6Y3, CA · 380 Elgin Mills Road East, Richmond Hill, Ontario L4C 5H2, CA · 34 Spalding Drive, Brantford, Ontario N3T 6B8, CA · 2400 N Commerce Pkwy, Suite 400, Weston, Florida 33326, US
At Apotex, we are a global team empowering everyone to achieve better health. We improve everyday access to affordable, innovative medicines and health products for people around the world, with a portfolio comprising more than 550 generic, biosimilar, and innovative medicines, along with more than 225 natural health products. Headquartered in Toronto, we are the largest Canadian-based pharmaceutical company and a health partner of choice in the Americas for pharmaceutical licensing and product acquisitions. Learn more about us at www.apotex.com.
To report an Adverse Reaction/Experience to Apotex, or an Apotex affiliated company, please contact: [email protected].
Offices: 150 Signet Drive, Toronto, Ontario M9L1T9, CA · 50 Steinway Boulevard, Etobicoke, Ontario M9W 6Y3, CA · 380 Elgin Mills Road East, Richmond Hill, Ontario L4C 5H2, CA · 34 Spalding Drive, Brantford, Ontario N3T 6B8, CA · 2400 N Commerce Pkwy, Suite 400, Weston, Florida 33326, US