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Apotex Research
2 Apotex Research Lead Jobs
8-9 years
Mumbai
1 vacancy
Lead Exec - Site Support - MPPD
Apotex Research
posted 2mon ago
Flexible timing
Key skills for the job
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, RD, 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.
For more information visit: www.apotex.com .
- Review of Batch process yield reports to ensure collected data is accurate conclusions are appropriate for Signet and Etobicoke sites.
Reviewing Batch process yield (BPYs) reports as assigned. This includes the following at minimum, as per SOP:
Review of issued e-copies and pre-executed documents ensuring document has met the quality levels.
Identify system improvements opportunities for drafting, template content/format and process efficiency.
Expert knowledge of SAP transactions used to support the SOD processes.
Responsible for Primary Technical Writer role for change control process for cancellation of documents for Signet and Etobicoke sites.
Monitoring of timeliness for submission quality compliance.
Review of MMaR / MPaR /SOD ensuring drafted data is complete, correct reproducible.
Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
Responses to reviewer s and project leader s queries for MMaR / MPaR /SOD /Metrics as required.
Identify system improvements opportunities for drafting, template content/format and process efficiency.
Liaise with TO TW and other internal customers to monitor efficiency and effectiveness in meeting targets for submissions.
Communicate findings to the leader and escalate any critical issues arising from the review.
Maintain the tracking systems for SOD processes.
Generate and provide monthly activity reports to the leader.
Create training materials and programs to support the product process.
Develop and maintain effective working relationships with internal and external customers.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and collaboration; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
All other duties as assigned.
Education
Bachelor s/ Master s degree in Science / Pharmacy
Knowledge, Skills and Abilities:
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.
Employment Type: Full Time, Permanent
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