Senior Quality Operations Specialist

4 days ago

Hyderabad, Telangana, India beBeeQuality Full time ₹ 1,17,00,000 - ₹ 1,63,00,000
Job Overview

Key Responsibilities:

  • Develops and maintains a quality assurance agreement with external partners, ensuring compliance with ADACAP and Novartis standards.
  • Responsible for the initial qualification and onboarding of contract manufacturers, as well as performing regular quality risk assessments to mitigate potential risks.
  • Ensures effective quality assurance agreements and relevant guidelines are implemented and maintained across the organization.
  • Manages and oversees contract manufacturer activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc.
  • Supports the Novartis audit of contract manufacturers and acts as QARP and/or FURP as required, promoting a culture of excellence and compliance.
  • Ensures change requests are managed according to the Quality Agreement and ADACAP change control procedures, maintaining continuity and consistency in our operations.
  • Reviews third-party documents from a quality point of view, identifying areas for improvement and implementing corrective actions.
  • Performs, coordinates, or archives GMP documentation as defined by the Quality Agreement and ADACAP SOPs, maintaining accurate and up-to-date records.
  • Initiates and drives quality improvement projects as required, fostering a collaborative environment that encourages innovation and growth.
  • Provides quality oversight on general topics as assigned, working closely with cross-functional teams to achieve shared goals.

Requirements:

  • At least 6 years of experience in pharmaceutical quality assurance, quality control, or manufacturing.
  • At least 3 years of experience in a Quality Assurance function, with a proven track record of maintaining quality oversight.
  • Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing, with a strong understanding of regulatory expectations.
  • Proven ability to maintain quality oversight on external partners, with excellent communication and interpersonal skills.
  • Experience with biological manufacturing would be an additional asset, with the ability to apply knowledge and skills in this area.
  • Strong analytical and problem-solving skills, with the ability to identify and mitigate potential risks.
  • Team player with definitive and authoritative decision-making ability, with a focus on collaboration and continuous improvement.

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