Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

RATE NOW!
- ABECA 2025
  
  RATE NOW!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Engaged Employer

Apotex Research

Compare

4.1

based on 761 Reviews

41 Apotex Research Jobs

Senior Executive, Stability Lab (Documentation)

APOTEX PHARMACHEM INDIA PRIVATE LIMITED

4.1

based on 761 Reviews

4-9 years

Bangalore / Bengaluru

1 vacancy

Senior Executive, Stability Lab (Documentation)

Apotex Research

posted 17d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy Manual Testing Excel Technical Writing Recruitment Analytical Chemistry

+ 3 more

Job Description

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

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

Read full job description