Locations- Bangalore, Hyderabad
General responsibilities,843
- Compliance and Standards: Ensuring adherence to global regulatory guidelines such as ICH, ICH-GCP, GMP and managing QMS and maintenance across products/ sites.
- Cross-functional Collaboration: Working with various client teams (e.g., RA, Manufacturing etc.) to ensure timely and accurate information and ongoing compliance. Monitor changes and ensure QA system compliance. Support audits and inspections by Notified Bodies and regulatory agencies by maintaining accurate records and submission history
Qualifications & Experience
- Preferably Postgraduate/ PhD. degree in Pharmacy/ Life Sciences, or a related field.
- 6-8 years in LS QA document control within GMP-regulated environments and including at least about 2 years experience in leading RA authoring team(s).
- Knowledge of and Proficiency in QMS platforms ( (e.g., Veeva QMS, MasterControl, Track-wise etc.) and electronic document management systems (EDMS) is mandatory.
- Good to have knowledge of eCTD, Lorenz, GlobalSubmit etc. Proven experience in requirement gathering, documentation, and stakeholder management, Familiarity with eCTD, IDMP, XEVMPD , and GxP compliance, Experience with CSV/validation support is a plus.
- Basic knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA & Global Health authority regulations).
- Excellent communication, collaboration, presentation and stakeholder management skills.
- Strong analytical, attention to detail and problem-solving abilities.
- Stable track record in LS Quality Assurance domain in a Mid-large Organisation.
- Proficiency in MS Office, Regulatory work processes and good knowledge of Global Regulatory submission requirements especially USFDA, MHRA, EMA, APAC, GCC, LatAm for Medical Devices and/or Medicinal/ Biotech products.
Skills:Systems & Tools Management,Document Control Systems,Version Control, QMS
Notice period - 0 to 15days only
Job stability is mandatory
Skills: qms,management,edms,stakeholder management
