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 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 ReportCross contamination quality risk assessment report for New product introduction at ARPL.Master Formula RecordsTechnology Transfer Protocol and Report for manufacturing and packagingTechnical Risk Evaluation of Products transferred from Apotex manufacturing sites to ARPL IndiaProcess Optimization Protocols & ReportsPlacebo Formulation sheetsTechnical Risk AssessmentPPQ & CPV Protocols & ReportsAnnual Product Quality Review.Change control Assessment for the following :New product introduction of site transfer products at ARPL.Master Manufacturing RecordsSpecifications (Inprocess SFG FP) and PV test profilesAssign batch number for Process Optimization batches and Placebo batchesEnsure archival of Process Optimization / Placebo batch documents to QA.Training on technical aspects to CFT as applicableMonitoring 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 :1)Cross contamination quality risk assessment report for New product introduction at ARPL.
2) Master Formula Records
3) Technical Risk Evaluation of new products
4) Process Demonstration / Optimization Protocols & Reports
5) Hold Study Protocols & Reports If any
6) Placebo Formulation sheets
7)Technical Risk Assessment
8) PPQ Protocols & Reports
9) Nitrosamine Risk Assessment Report
10) CPV Protocols & Reports
Assign / review of Protocol and Report Numbers for Process Optimization batches and Placebo batchesTraining 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 formTechnical Risk EvaluationProcess Optimization Protocols & Reports if anyProcess Demonstration Protocols & Reports if anyProcess verification Protocols & Reports if anyJob Requirements
Supplier Driven changes (SDC) :Change control Assessment for the following :Supplier driven change.Specifications (Inprocess SFG FP) and PV test profilesPreparation / review of the following technical ldocuments with respect to SDC products :Material Assessment Report for Alternate API / Excipient Source.Master Formula RecordsTechnical Risk Evaluation of SDC productsProcess Optimization Protocols & Reports if anyProcess Demonstration Protocols & Reports if anyProcess verification Protocols & Reports if anyTechnical Risk Assessment if anyPPQ Protocols & Reports if anyCPV Protocols & ReportsAnnual Product Quality ReviewPlacebo formulation sheetAssign batch numbers for Process Optimization batches and Palcebo batchesDocumentation :Prepare / review the following documentation requirements for the MS&T activities
Product code AllocationAllotment of batch number for Optimization and placebo trials batchesMaster formula Record.Technology transfer Protocol and Report for Manufacturing & PackagingTechnical Risk evaluationProcess optimization Protocol & Report.Process demonstration Protocol & Report.Technical Investigation reportSubject Matter expert analysis report.Technical Summary report.Material Assessment Report.Placebo Formula sheetTechnical Summary reportProcess Performance Qualification (PPQ) Protocol & ReportContinued Process Verification (CPV) Protocol & ReportHold time study Protocol & ReportMaster Manufacturing Record (MMaR) AssessmentChange control AssessmentsOther documentation activities Eg : but not limited toJustification report
Manufacturing Process comparisonTraining documentationPre-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.EducationMaster Degree in Pharmacy
ExperienceMinimum 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 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 :
Manager
Key Skills
Business Process,SQL,Active Directory,Information Technology,Database,Information Security,Infrastructure,ITIL,Project Management,Internet,ERP,Backup,Setup,hardware,Technical Support
Employment Type : Full Time
Experience : years
Vacancy : 1
