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.
Coordinate, document, and validate manufacturing and packing activities, monitor validation requirements, and support regulatory submissions and product launches/Site transfer.

Job Responsibilities

Site technology Transfer:

Prepare, review, and update standard operating procedures and Validation Master Plan.
Coordinate and review quality risk management (QRM).
Prepare and review cleaning validation protocols and reports. Perform cleaning validation product risk assessments to identify worst-case molecules for cleaning validation.
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.
Prepare for regulatory audits and ensure compliance.
Prepare and review Annual Product Quality Review (APQR) and data trending for products (3B).
Review and approve process validation protocols and reports for demonstration, optimization, qualification, and verification batches.
Prepare and review process validation and APQR activities in QMS Trackwise.
Conduct QA assessments for change control, action items, and review MDoc from various departments in QMS Trackwise.
Coordinate periodic self-inspection activities.
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.
Preparation of following technical documents with respect to site transfer:
Cross contamination quality risk assessment report for New product introduction at ARPL.
Master Formula Records
Technical Risk Evaluation of Products transferred from Apotex manufacturing sites to Apotex research private limited (ARPL), India
Process Optimization Protocols & Reports
Process Demonstration Protocols & Reports
Hold Study Protocols & Reports If any
Placebo Formulation sheets
Technical Risk Assessment
PPQ Protocols & Reports
CPV Protocols & Reports
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Ensure archival of Process Optimization/Placebo batch documents to QA.
Any other activities as assigned related to site technology transfer.

Technology Transfer Of New Products:

Preparation 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 Optimization Protocols & Reports
Process Demonstration Protocols & Reports
Hold Study Protocols & Reports If any
Placebo Formulation sheets
Technical Risk Assessment
PPQ Protocols & Reports
Nitrosamine Risk Assessment Report
CPV Protocols & Reports
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Any other activities as assigned related to New product launch.

Manufacturing Process Support:

Troubleshooting of processing issues for commercial batch manufacturing at shop floor.
Manufacturing process support in the event of any issues which are unplanned and require immediate resolution.
Draft technical summaries, investigation reports, or SME responses following QMS TrackWise Investigation procedures.

Job Requirements

Product Life cycle Management (PLCM):

Preparation of the following technical documents with respect to PLCM products:
Technical summary report
Technical Investigation Report.
PLCM form
Technical Risk Evaluation
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
CPV Protocols & Reports
Monitoring of Process Optimization/Process demonstration/PPQ batches.
Assign batch numbers for Process Optimization batches

Supplier Driven Changes (SDC):

Preparation of the following technical documents 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
Placebo formulation sheet
Monitoring of Process Optimization/Process demonstration/PPQ/Procss Verification batches.

Documentation:

Preparation of the following documentation requirements for the MS&T activities,

Master formula Record.
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
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.
Ensure work complies fully with GMP, SOPs, safety standards, and regulatory requirements.
Coordinate with Mfg, Pkg, FD, WH, and QA for document approvals, technical 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
Execute other assigned duties based on subject expertise, following directives from the Head of MS&T.

Job Requirements:

Education

Master Degree in Pharmacy or Science.

Knowledge, Skills and Abilities

Essential knowledge: Solid dosage process development and technology transfer for regulated markets.
Requires strong understanding of product development, scale-up, and process validation.
Needs strong understanding of clinical and regulatory requirements for USA, Canada, Australia, EU.
Should have good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet
Possesses/develops the ability to adapt to frequent changes in priorities and schedules.
The willingness to upgrade knowledge/education on an on-going basis.

Experience

Minimum 2-5 years of experience in GMP Regulated industry.

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.

Senior Executive - Manufacturing, Science, And Technologies