Expert in Quality Operations

3 hours ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000
Quality Assurance Specialist

Job Summary:

  • Develops and maintains Quality Assurance Agreements in cooperation with external partners.
  • Responsible for the initial qualification and onboarding of contract manufacturers as well as performing regular quality risk assessments.
  • Ensures all aspects of manufacturing, testing, release and distribution of drug substance/drug product/intermediate product/material are in compliance with applicable standards, guidelines and quality management systems.
  • Manages and oversees contract manufacturers' activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc.
  • Ensures investigations are appropriately executed within agreed timelines, including documentation and effective measures to prevent recurrence.
  • Supports audits of contract manufacturers and acts as QARP and/or FURP as required.
  • Manages change requests from receipt through implementation and closure.
  • Reviews third-party documents from a quality point of view.
  • Performs, coordinates or archives GMP documentation as defined by SOPs.
  • Responsible for compiling product quality reviews in cooperation with external partners.
  • Initiates and drives quality improvement projects as required.
  • Supports the quality function on general topics assigned.
  • Writes and maintains concept descriptions of assigned topics and presents them in audit situations.
  • Develops related procedures or provides input as needed.
  • Escalates significant quality incidents and supply risks as per escalation policies to management.
  • Reports and trends key performance indicators per assigned contract manufacturers.
  • Implements and maintains a local Quality System and Standard Operating Procedures defining all processes for managing external suppliers.

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