Executive, Ms
6 days ago
**About Apotex Inc.**
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
**Job Summary**:
- Documentation: Documentation support for the site technology transfer activities at ARPL
- All other relevant duties as assigned.
**Responsibilities**:
- Site technology Transfer Documentation:
- Preparation of following technical ldocuments with respect to site transfer:
- 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 Apotex research private limited (ARPL), India
- Process Optimization/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
- Justification reports
- Manufacturing Process comparison
- Training documentation
- Pre-requisite checklists (Part A & Part B)
- Revision of Standard Operating procedure, Formats.
- Ensure archival of Process Optimization/Placebo batch documents to QA.
- Any other activities as assigned related to site technology transfer.
- 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, SCM, WH,QC, QA Validation related to document review and approvals.
- 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.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage,Perseverance,and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
**Job Requirements**:
- Education
- B.Pharma/Master Degree in Pharmacy or Science.
- Experience
- 2 year-4 years
- Knowledge, Skills and Abilities:
- Should have knowledge of process development and Technology transfer documentation on Solid dosage forms for regulated markets like USA, Europe, Canada and Australia is essential.
- 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.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers 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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