About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.
Responsible for processing and managing changes required to Master Production and Packaging documentation; maintaining the Document management system for Apotex Signet.
- Responsible for creating and/or making formatting changes and edits to Master Manufacturing Records (MMaRs) and Master Packaging Records (MPaRs) based on supporting documentation from Business Units (i.e. Technical Operations Reports, Validation Reports)
- Conduct Detailed Impact Analysis for MMaRs and MPaRs according to proposed Change Requests. Detailed Impact Analysis includes but is not limited to the following:
- Assess MMaR/MPaR structure and state
- Identify compliance requirements within the process of the MMaR and/or MPaR
- Assess and update relevant SOD references
- Impact of change on overall Product Family, Markets, Strengths
- Serve as a technical resource to internal/external customers and key stakeholders in the development of documents by advising on current Document Naming Conventions, Active Standard Instruction requirements & Master Template issues. Provide training to new team members as required.
- Ensure changes outlined in the change management system coincide with mark-ups and/or proposed change, and all related documents/data affected are captured.
- Collaborate with SME/CO to facilitate the compiling of supporting documentation (i.e. markups, drafts), and to provide documentation related technical support. Alert the CO of time-related issues as necessary.
- Adhere to established Technical Writer Standard Work.
- Responsible for initiating required changes in the change management system and possesses strong knowledge in the use of the application.
- Detail the change(s) and the corresponding rationale(s), applying root cause analysis principles (e.g. The 5 Whys).
- Assign document codes according to current Document Naming Conventions, ensure accurate correlation with corporate applications.
- Conduct review of documents/reports produced by GBS and provide feedback. Collaborate with GBS on document drafting and execution activities.
- Acts as the liaison between the SME/Change Owner, QA Document Reviewer, and Master Data Maintenance Specialist to implement documentation changes as per change request.
- Monitors rejections during the Business Impact process and participates in issue resolution.
- Manage current electronic files and maintain corresponding change control and revision history in the Corporate Document Management system.
- Perform functions related to scanning/posting and publishing approved documents on the Apotex Intranet.
- Maintain SAP transactions for automated Master document issuance.
- Report anomalies and communicate any changes required for correcting discrepancies found in all MMaRs/MPaRs to Supervisor. (i.e. Deviation Investigations and Corrective/Preventative Actions stemming from Temporary changes)
- Support other department deliverables such as generation of Batch Process Yield Reports, Production Memos, and unblocking of documents.
- Complete projects with strict deadlines and within established cycle time commitments under minimal supervision. Able to prioritize workload to deliver as per business needs.
- 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.
- Post-Secondary education required, University degree in related discipline preferred.
- Knowledge, Skills and Abilities:
- Understanding of GMPs, SODs.
- Strong verbal and written English communication skills.
- Demonstrated knowledge of organizational structure and functions across Apotex and affiliates.
- Good organization skills and report writing skills.
- Proficient in working with MS Office Suite (Microsoft Word, Excel).
- Well developed interpersonal and team work skills.
- Working knowledge of a document management system an asset.
- Ability to be flexible and multi-task in a rapidly changing environment.
- Ability to complete and coordinate projects with strict deadlines.
- Minimum of three years relevant working experience in the pharmaceutical industry.
- Experience in and proficient use of Microsoft Office software, in network environment.
- SAP experience an asset
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.
We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.
Other measures Apotex has put into place include (but are not limited to):
- staggering employee shifts to reduce the size of work groups
- modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines
- robust self-assessment and screening tools
- non-surgical masks for employees working in GMP areas
- travel restrictions
- work-from-home policy for all employees who can perform their roles remotely
- strict visitor screening protocol
It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.
For up-to-date information about Apotex's ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter