Senior Exec, Mfg Sci & Tech
Senior Exec, Mfg Sci & Tech
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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.
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Job Summary
- Site technology Transfer:
- Internal product technology transfers from an Apotex manufacturing site to Apotex research privatelimited (ARPL) India.
- Transfer of products from Small Volume Manufacturing Plant to Large Volume Manufacturing Plantand Vice versa within ARPL.
- Technology transfer of New products:
- New product transfer from formulation development to commercial scale.
- Manufacturing process support: Technical support for the trouble shooting of processing issues in Commercial batch manufacturing.
- Product Life cycle Management (PLCM) : Technical support to ensure robustness of product/process through out its life cycle.
- Supplier driven changes (SDC) : Change or addition of a source or supplier driven change in raw material (API & Excipients) manufacturing process for existing commercial products.
- Documentation: Documentation support for the MTS activities.
- All other relevant duties as assigned.
Job Responsibilities
- Site technology Transfer:
- Prepare necessary documents to support manufacturing license of technical documents with respect to site transfer such as Form-CMFRTechnology Transfer Protocol and ReportTRE Protocols and reports for POPDPPQCPV and Hold Study batchesPlacebo Formulation of PO/PD/PPQ archival of PO/Placebo batch documents to QA and any other activities as assigned.
- Technology transfer of New products:
- Preparation of the technical documents with respect to Technology transfer of new products such as Form-CMFRTREProtocols and reports for POPDPPQCPV and Hold Study batchesPlacebo Formulation sheetsTRA Monitoring of PO/PD/PPQ batches and any other activities as assigned.
- Manufacturing process support:
- Troubleshooting of processing issues for commercial batch manufacturing at shop process support in the event of any issues which are unplanned and require immediate resolution.
- Product Life cycle Management (PLCM):
- Preparation of the technical documents with respect to PLCM products such as TRE Protocols & Reports for POPDProcess verificationPPQ and CPV batchesTRA. Monitoring of PO/PD/PPQ batches.
- Supplier Driven changes (SDC):
- Preparation of the technical documents with respect to SDC products such as MARMFRTREProtocol & Report forPOPDProcess verificationPPQ & CPV batchesTRA Placebo formulation sheet. Monitoring of PO/PD/PPQ/Procss Verification batches.
- Documentation:
- Justification reportsManufacturing Process comparisonTraining documentationPre-requisite checklistsRevision of Standard Operating procedure Formats.
- Ensure work is performed in full compliance with good manufacturing practices standard operating procedures established safety standards and regulatory requirements. Coordinate with various departments such as Mfg Pkg FD WH QA Validation related to document review and approvalstechnical processing issues and equipment perform all work in accordance with all established regulatory and compliance and safety requirements.
Job Requirements
- Education
- Master Degree in Pharmacy or Science.
- Experience:
- Fresher
- Knowledge Skills and Abilities:
- Should have theoretical knowledge of process development and Technology transfer on Solid dosage forms.
- Should have a good theoretical understanding of 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 and possesses/develops the ability to adapt to frequent changes in priorities and willingness to upgrade knowledge/education on an on-going basis.
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.
Required Experience:
Senior IC
Employment Type
Full Time
