Senior Exec, Mfg Sci

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.

For more information visit: www.apotex.com.

Job Summary

- Site technology Transfer:

- Internal product technology transfers from an Apotex manufacturing site to Apotex research private limited (ARPL), India.
- Transfer of products from Small Volume Manufacturing Plant to Large Volume Manufacturing Plant and 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 application.Preparation of technical documents with respect to site transfer such as Form-C,MFR,Technology Transfer Protocol and Report,TRE, Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA.Monitoring of PO/PD/PPQ batches.Ensure 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-C,MFR,TRE,Protocols and reports for PO,PD,PPQ,CPV and Hold Study batches,Placebo Formulation sheets,TRA, 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 floor.Manufacturng 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 PO,PD,Process verification,PPQ and CPV batches,TRA. Monitoring of PO/PD/PPQ batches.

- Supplier Driven changes (SDC):

- Preparation of the technical documents with respect to SDC products such as MAR,MFR,TRE,Protocol & Report forPO,PD,Process verification,PPQ & CPV batches,TRA, Placebo formulation sheet. Monitoring of PO/PD/PPQ/Procss Verification batches.

- Documentation:

- Justification reports,Manufacturing Process comparison,Training documentation,Pre-requisite checklists,Revision 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 approvals,technical processing issues and equipment failures.To 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 schedules.The 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.

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