Senior Executive, Stability Lab (Documentation)

Job Summary

Responsible for reviewing of all analytical data generated in ARD-Test Centre in compliance with cGMP and related SOPs and preparing reports for submission to the Regulatory agencies.

Primarily responsible for creating and revising all analytical test methods (chemical and physical) and specifications generated in Analytical R&D as per current Apotex format and posting the methods on Apoweb. Responsible for the completion of R&D Change Control Requests (CCRs) in Trackwise for method creation to transfer of methods to the commercial site. Responsible for support and completion of R&D CCRs in Trackwise for generation and update of specifications. Also responsible for creating, updating and maintanance of Apotex technical report templates.

This person is seen as a leader and acts as a backup-supervisor for all project updates or queries on submission documents.

Job Responsibilities

• Requests product codes for new projects from Consultant, Financial data Processes (for SAP product codes) or from Supervisor, NPL-Master Prod&Pkg Docs (for product acronyms) and assigns new method numbers for Analytical R&D and ARPL, as applicable, using Excel database.
• Creates and revises analytical test methods generated in Analytical R&D using current method templates, for example: chromatographic methods, physico-chemical test methods, dissolution test methods.
• Assists PD-SD chemists, Chemistry & Compendia associates, and ARD scientific leaders with CCR creation and reviews all associated documents prior to management approval.
• Initiates and supports change controls as relevant to R&D specifications.
• Liaises with Analytical R&D, Commercial labs, QC Documentation group, RA and R&D QA for CCR’s signatures and impact analysis.
• Checks the method files into Content Server and creates workflow in Workflow Manager.
• Posts all analytical methods on Apoweb (Analytical Test methods site), maintains the site archive, and adds all new product/excipient names to the Apoweb.
• Creates and maintains Excel database of R&D analytical methods and the method change histories.
• Communicates the status of analytical method and R&D specifications change control to relevant parties in a timely manner.
• Works with ARD Scientific Leaders and supervisors to ensure test method templates are current.
• Creates, updates and maintains ARD technical report templates (including those for global regulatory submissions).
• Ensures all analytical tests are done according to the test method, GMP, SOP/WI and Guidelines
• Reviews all analytical data generated by ARD-QC lab. Understands the detailed analytical procedures and guidelines.
• Liaise with other units within GRD to ensure that all information required for stability protocol is completed.
• Review the stability protocols in LIMS.
• Reviews the Laboratory investigations and deviations for accuracy, compliance and completeness.
• Reviews analytical data pertaining to the analytical testing of drug substance, in-process sample, drug products and excipients.
• Reviews analytical data pertaining to additional tasks required for the submission such as comparative dissolutions studies, stability studies, photostability studies, dissolution pH & Alcohol Dose Dump studies and impurity surveys.
• Reviews analytical data pertaining to validation and technology transfer of analytical testing procedures of drug substances and drug product.
• Verifies the integrity and traceability of all data reported.
• Ensures the accuracy of calculations and that the test method and relevant SOP’s/WIs have been followed during the performance of the analytical test. · Prepares various analytical summary reports such as comparative dissolution report, stability summary reports, photostability report, impurity surveys, PH dissolution report, Alcohol Dose Dump studies report and test article report for clinical studies. Ensures the above reports with accurate content are published on ERS.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensures personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, health and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education/Experience
  • A graduate/postgraduate or Ph.D. degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Sound working and theoretical knowledge of automated laboratory instrumentations.
  • Knowledge of basic principles of major analytical techniques and associated scientific calculations.
  • Knowledge of Excel, Word, other Microsoft Office Programs and laboratory software packages.
  • Excellent Verbal and written English communication skills.
  • Excellent typing and proofreading skills.
  • Knowledge of compliance and regulatory requirements
  • Working knowledge of SAP is an asset
• Experience
  • 8+ year experience in pharmaceutical industry as document reviewer and technical Writing, preferably in R&D environment