Technical Writer, Pharmaceutical Manufacturing

**About Apotex Inc.**

**Job Summary**:
Responsible for processing and managing changes required to Master Production and Packaging documentation; maintaining the Document management system for Apotex Signet.

**Responsibilities**:

- Responsible for creating &/or making formatting changes & edits to Master Manufacturing Records (MMaRs) & Master Packaging Records (MPaRs) based on supporting documentation from Business Units (i.e. Technical Operations Reports, Validation Reports)
- Conduct Detailed Impact Analysis for MMaRs & MPaRs according to proposed Change Requests. Detailed Impact Analysis includes but is not limited to the following:

- Assess MMaR/MPaR structure & state
- Identify compliance requirements within the process of the MMaR &/or MPaR
- Assess & update relevant SOD references
- Impact of change on overall Product Family, Markets, Strengths
- Serve as a technical resource to internal/external customers & 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 &/or proposed change, & all related documents/data affected are captured.
- Collaborate with SME/CO to facilitate the compiling of supporting documentation (i.e. markups, drafts), & to provide documentation related technical support. Alert the CO of time-related issues as necessary.
- Adhere to established Technical Writer Standard Work.
- Conduct review of documents/reports produced by GBS & provide feedback. Collaborate with GBS on document drafting & execution activities.
- Acts as the liaison between the SME/Change Owner, QA Document Reviewer, & Master Data Maintenance Specialist to implement documentation changes as per change request.
- Monitors rejections during the Business Impact process & participates in issue resolution.
- Manage current electronic files & maintain corresponding change control & revision history in the Corporate Document Management system.
- Perform functions related to scanning/posting & publishing approved documents on the Apotex Intranet.
- Maintain SAP transactions for automated Master document issuance.
- Report anomalies & communicate any changes required for correcting discrepancies found in all MMaRs/MPaRs to Supervisor. (i.e. Deviation Investigations & Corrective/Preventative Actions stemming from Temporary changes)
- Support other department deliverables such as generation of Batch Process Yield Reports, Production Memos, & unblocking of documents.
- Complete projects with strict deadlines & within established cycle time commitments under mínimal 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, & Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies, & HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education:

- 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.
- Experience:

- Minimum of three years relevant working experience in the pharmaceutical industry.
- Previous experience preparing document in the pharmaceutical industry is preferred.
- 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.