Specialist - Quality Control

4 days ago

Mumbai, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 28,00,000

Job Title: Specialist - Quality Operations

This position is a key member of the Quality team, responsible for managing and resolving complaints from suppliers.

Key Responsibilities:
  • Receive and review initiated complaints in the QMS tool. Process technical complaints to CMO/Supplier for investigation.
  • Coordinate complaint sample availability, additional information from Country Organization (CO) to CMO and vice versa as needed.
  • Periodic follow-up of complaints with supplier for timely investigation. Perform queries in QMS tools like GxQEM as per procedures.
  • Reviewing supplier investigations and completing them in the QMS tool for complaints delegated to GQSI. Perform QA approver duties for complaints delegated to GQSI.
  • Tracking and extension of complaint/actions as per requirements. Complete assigned tasks as per business needs.
  • Management of Child records such as Investigation, Communication action etc. as required.
  • Participate in meetings/discussions between sites and suppliers over supplier complaints as needed.
  • Perform Quarterly complaint/deviation trending and reporting. Evaluate Signals and further management in the QMS tool.
Requirements:
  • Minimum 7 years of experience in Quality Assurance, Regulatory or manufacturing of pharmaceutical drug substances/products/medical devices.
  • GxP knowledge, basic IT knowledge.
  • Experience working closely with global stakeholders.
Language Skills:
  • Fluent in English (written and spoken).
  • Good communication, presentation, and interpersonal skills.
Benefits:

Languages provide an essential means of communicating effectively with colleagues, clients, and stakeholders across different regions. Proficiency in a language can enhance professional prospects, increase work opportunities, and boost career advancement. In this role, you will have the opportunity to develop and utilize your language skills in a dynamic and supportive environment.

Additional Information:

The ideal candidate should be able to demonstrate strong problem-solving skills, attention to detail, and excellent organizational abilities. Additionally, they should possess effective communication skills, both written and verbal, and be able to work independently with minimal supervision. If you are a motivated individual looking for a challenging role in a dynamic organization, please submit your application today.

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