Lead Exec Site Support MPPD

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.
For more information visit: www apotex com .
Job Summary.
Responsible for the following aspects of the Batch process yield (BPY) program;.
Review of Batch process yield reports to ensure collected data is accurate & conclusions are appropriate for Signet and Etobicoke sites.
Responsible to escalate any critical issues arising from the product review.
Responsible for the following aspects for the review of MMaR / MPaR and SOD.
Accountable to ensure the submission of MMaR / MPaR and SOD to the counterpart in a timely manner and as per established procedures.
Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.
cts as a technical resources and coach for the team and affiliates in regard to the MMaR / MPaR and SOD procedure.
Generation of Metrics for Signet site.
Develop & mentor the GSTO technical writer to meet the quality levels.
Job Responsibilities.
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 reviewers and project leaders 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 employees 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.
Job Requirements.
Education.
Bachelors/ Masters degree in Science / Pharmacy.
Knowledge, Skills And Abilities.
Should be proficient in MS office tools.
Should have excellent verbal & written communication skills.
Experience of working on online modules / software would be an added advantage.
Well-developed interpersonal and team work skills.
Demonstrate leadership and presentation skills.
Working knowledge of a document management system required.
Ability to be flexible and multi-task in a rapidly changing environment.
Ability to complete and coordinate projects with strict deadlines.
Experience.
Minimum 8-9 years of experience in the Pharmaceutical industry.
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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