Pharmacy Job for Freshers at Apotex | Apply Now for the Senior Executive Role
Apotex is seeking a Senior Executive – Manufacturing, Science & Technology (MS&T) for its Bangalore facility. This Pharmacy Job is designed for a Fresher with a Master’s Degree in Pharmacy or Science who possesses theoretical knowledge of technology transfer and process development for solid dosage forms. The Apotex Job focuses on internal site transfers, new product scaling from formulation to commercial manufacture, and providing technical support for commercial batch troubleshooting and Product Life Cycle Management (PLCM).
- Job Title: Senior Executive – Manufacturing, Science & Technology
- Location: Bangalore, KA, IN, 560099
About Apotex
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.
Pharmacy 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 troubleshooting of processing issues in Commercial batch manufacturing.
- Product Life Cycle Management (PLCM): Technical support to ensure robustness of product/process throughout its lifecycle.
- 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 applications. 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 the shop floor. Manufacturing 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 for PO, PD, Process verification, PPQ & CPV batches, TRA, Placebo formulation sheet. Monitoring of PO/PD/PPQ/Process Verification batches.
- Documentation: Justification reports, Manufacturing Process comparison, Training documentation, Pre-requisite checklists, Revision of Standard Operating Procedure, and 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.
Apotex Job Requirements
- Education: Master’s 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 possess/develop the ability to adapt to frequent changes in priorities and schedules. The willingness to upgrade knowledge/education on an ongoing basis.
