Quality Assurance Specialist

6 days ago

Hyderabad, Telangana, India Lifelancer Full time
About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Lifelancer. As a Quality Assurance Specialist, you will be responsible for managing Quality aspects and projects within your area of responsibility, ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems.

Key Responsibilities
  • Manage Quality aspects and projects within your area of responsibility.
  • Ensure and support overall GxP conformity and Compliance with the Novartis Quality Management Systems.
  • Interpret and compile APQR and/or extracted data from Internal Novartis systems into a predefined template and draft conclusion of product quality review.
  • Create and review GxP documents, including SOPs, working procedures, trend reports, qualification, reports, and technical investigations as and when needed.
  • Provide active support during internal and external audits by collecting and presenting the requested process/data and reports.
  • Adhere to the current GxP and compliance policies of Novartis, Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows.
  • Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, TEDI, etc.) to ensure appropriate service deliverables.
  • Generate and analyze predefined and ad-hoc reports in various applications (such as AGILE, PLM, AQWA, etc.) and perform follow-up actions if required.
  • Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements.
  • Support implementing service quality and process improvement projects, CAPA management within Quality Service Centers.
  • Comply with all internal functional operating procedures, like time tracking, KPI reporting, ticket management tools, and other internal systems and processes.
Requirements
  • Minimum 6 years of experience in Quality assurance activities in a pharmaceutical company.
  • GxP knowledge, Basic IT knowledge.
  • Good communication, presentation, and interpersonal skills.
  • Experience of working closely with global stakeholders.
Skills
  • Continuous Learning.
  • Dealing With Ambiguity.
  • Gmp Procedures.
  • Qa (Quality Assurance).
  • Quality Control (Qc) Testing.
  • Quality Standards.
  • Self-Awareness.
  • Technological Expertise.
  • Technological Intelligence.
Languages

English.

At Lifelancer, we are committed to helping people with disease and their families. We believe that collaborating, supporting, and inspiring each other is key to achieving breakthroughs that change patients' lives. If you are passionate about quality and compliance, and want to be part of a community that makes a difference, we encourage you to apply for this exciting opportunity.

Please use the below Lifelancer link for job application and quicker response.

/jobs/view/f0bdb6a09b306039f7d57ecf

Remote Work : No

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