Quality Assurance Specialist

2 days ago

Hyderabad, Telangana, India beBeeQuality Full time ₹ 12,00,000 - ₹ 15,00,000

Job Title: Quality Assurance Expert

 

We are seeking a highly skilled Quality Assurance Expert to join our team. In this role, you will be responsible for ensuring the quality of pharmaceutical drug substances and products.

 

Key Responsibilities:
  1. Manage Quality aspects projects within area of responsibility including coordination and management of analytical method transfers and stability studies.
  2. Compilation of data reports and life-cycle management of analytical methods including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements.
  3. Handling of deviations investigation, OOS, OOE and OOT cases as well as changes and complaints.
  4. Perform statistical data analysis to report Out of Expectations, OOE out of trends etc.
  5. SAP master data management, maintenance of master data, creation of Q-info records and other SAP related activities.
  6. Validate spreadsheets, collect, transcribe and/or compile data from various repositories SAP, LIMS, external COAs.
  7. Author, approve and archive impurity risk assessments, Nitrosamines, residual solvents etc.
  8. Trend and report all QMS elements as per request.
  9. Monitor, trend and report Health Safety and Environmental parameters.
  10. Implementation of GMP requirements, compilation and review of documents, analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents, Common Technical Document modules.
  11. Perform activities of a Quality Control expert as defined by respective sites.
  12. Support regulatory requirements, routine queries, Chromatogram requests.
  13. Compile Quality performance management decks.
  14. Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations as and when needed.
Requirements:
  • Pharmacy, Science, MBA, Engineering equivalent from reputed institute.
  • Min 3 years of experience in Quality Assurance, Regulatory or in manufacturing of pharmaceutical drug substances, products, medical devices.
  • GxP knowledge.
  • Basic IT knowledge.
  • Good communication, presentation and interpersonal skills.
  • Experience of working closely with global stakeholders.
Skills:
  • Continuous Learning.
  • Dealing With Ambiguity.
  • Good understanding of GMP Procedures.
  • Quality Assurance, Quality Control, Testing, Quality Standards.
  • Self Awareness.
  • Technological Expertise, Technological Intelligence.
Language Skills:
  • Fluent in English, written and spoken.

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