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.
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 MS&T activities
All other relevant duties as assigned.

Job Responsibilities

Site technology Transfer:
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.
Prepare and review cleaning validation documents;.
Cleaning validation related activiteds and e-Residue software application activities.
Prepare and review PDE changes.
Prepare and review of quarterly and annual monitoring reports for cleaning validation.
Preparation/review following technical ldocuments with respect to site transfer:
Site transfer strategy Report
Cross contamination quality risk assessment report for New product introduction at ARPL.
Master Formula Records
Technology Transfer Protocol and Report for manufacturing and packaging
Technical Risk Evaluation of Products transferred from Apotex manufacturing sites to ARPL, India
Process Optimization Protocols & Reports
Placebo Formulation sheets
Technical Risk Assessment
PPQ & CPV Protocols & Reports
Annual Product Quality Review.
Change control Assessment for the following:
New product introduction of site transfer products at ARPL.
Master Manufacturing Records
Specifications (Inprocess, SFG, FP) and PV test profiles
Assign batch number for Process Optimization batches and Placebo batches
Ensure archival of Process Optimization/Placebo batch documents to QA.
Training on technical aspects to CFT as applicable
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Any other activities as assigned related to site technology transfer.
Technology transfer of New products:
Change control Assessment for the following:
New product introduction at ARPL.
Master Manufacturing Records.
Specifications (Inprocess, SFG, FP) and PV test profiles.
Preparation/review 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 Demonstration/Optimization Protocols & Reports
Hold Study Protocols & Reports If any
Placebo Formulation sheets
Technical Risk Assessment
PPQ Protocols & Reports
Nitrosamine Risk Assessment Report
CPV Protocols & Reports
Assign/review of Protocol and Report Numbers for Process Optimization batches and Placebo batches
Training on technical aspects to CFT as applicable.
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Any other activities as assigned related to New product launch.
Manufacturing process support:
Troubleshoot and support unplanned manufacturing issues on the floor immediately.
Write technical investigation reports (QMS).
Product Life cycle Management (PLCM):
Preparation/review of the following technical ldocuments with respect to PLCM products:
Technical summary report (TSR)
Technical Investigation Report (TIR).
PLCM form
Technical Risk Evaluation
Process Optimization Protocols & Reports if any
Process Demonstration Protocols & Reports if any
Process verification Protocols & Reports if any

Job Requirements

Supplier Driven changes (SDC):
Change control Assessment for the following:
Supplier driven change.
Specifications (Inprocess, SFG, FP) and PV test profiles
Preparation/review of the following technical ldocuments with respect to SDC products:
Material Assessment Report for Alternate API/Excipient Source.
Master Formula Records
Technical Risk Evaluation of SDC products
Process Optimization Protocols & Reports if any
Process Demonstration Protocols & Reports if any
Process verification Protocols & Reports if any
Technical Risk Assessment if any
PPQ Protocols & Reports if any
CPV Protocols & Reports
Annual Product Quality Review
Placebo formulation sheet
Assign batch numbers for Process Optimization batches and Palcebo batches
Documentation:

Prepare/review the following documentation requirements for the MS&T activities,

Product code Allocation
Allotment of batch number for Optimization and placebo trials batches
Master formula Record.
Technology transfer Protocol and Report for Manufacturing & Packaging
Technical Risk evaluation
Process optimization Protocol & Report.
Process demonstration Protocol & Report.
Technical Investigation report
Subject Matter expert analysis report.
Technical Summary report.
Material Assessment Report.
Placebo Formula sheet
Technical Summary report
Process Performance Qualification (PPQ) Protocol & Report
Continued Process Verification (CPV) Protocol & Report
Hold time study Protocol & Report
Master Manufacturing Record (MMaR) Assessment
Change control Assessments
Other documentation activities Eg: but not limited to
Justification report
Manufacturing Process comparison
Training documentation
Pre-requisite checklists (Part A & Part B)
Revision of Standard Operating procedure, Formats.
Coordinate with the GTA team to make sure the technology transfer to ARPL is timely, robust, and results in a validation-ready product.
Ensure work complies with GMP, SOPs, safety, and regulations; manage employees safely.
Liaises with various departments such as Mfg, Pkg, FD, WH, QA Validation regarding pertinent issues related to materials, batch records, technical processing issues and equipment failures.
To work as a member of a team to achieve all outcomes.
To perform all work in accordance with all established regulatory and compliance and safety requirements.
Education

Master Degree in Pharmacy

Experience

Minimum 11 years of experience in Technology Transfer of the Pharmaceutical product / Formulation development for regulated market

Knowledge, Skills And Abilities

Should have knowledge of process development 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 understanding of clinical and regulatory requirements of USA, Canada, Australia, and European regulatory agencies.
Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.

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.

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