Base Career helps you apply smarter for this job.
Key skills for this role
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.
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.
For more information visit: www.apotex.com .
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.
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.
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
Bengaluru, IND
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,
Bengaluru, IND
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,
, CAN
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,
, CAN
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,
, CAN
, CAN
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,
Richmond Hill, CAN
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,
, CAN
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,
Bengaluru, IND
Bengaluru, IND
, CAN
, CAN
, CAN
, CAN
Richmond Hill, CAN
, CAN
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.
Preparation of the following technical documents with respect to Technology transfer of new products
Technical Risk Evaluation of new products
Nitrosamine Risk Assessment Report
Any other activities as assigned related to New product launch.
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 .
Canadian pharmaceutical company producing generic, biosimilar, branded, and consumer health medicines for patients worldwide.
Visit company websiteJobs and hiring trendsFull-time
Mid · 3+ years experience
Onsite
Apply faster on company sites with our extension.