Operational Excellence Lead

1 week ago

Hyderabad, Telangana, India beBeeExpertise Full time ₹ 25,00,000 - ₹ 45,00,000
Quality Operations Expert

 

The ideal candidate will have at least 6 years of experience in pharmaceutical quality assurance, quality control or manufacturing and a proven track record of maintaining quality oversight on external partners. He/She will be responsible for ensuring that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable standards.

Key Responsibilities:
  • Develops and maintains a Quality Assurance Agreement in cooperation with the external partners.
  • Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments.
  • Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable standards, relevant guidelines and the Quality Management System of the external partners.
  • Manages and oversees contract manufacturer's activities related to quality processes such as deviations, complaints, recalls, counterfeits, product tampering, stability failures, etc. according to the Quality Assurance Agreement and the company's quality manual.
  • Supports the quality function on general topics as assigned. Writes and maintains general concept descriptions of the assigned topics and presents the assigned topic in audit situations.
  • Escalates significant quality incidents and supply risks as per escalation policies to management.
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.
  • Thorough knowledge of cGMP requirements and their practical application in routine biological manufacturing.
  • Proven track record of maintaining quality oversight on external partners.
  • Good communication skills.
  • Team and consensus builder, with definitive and authoritative decision making ability.

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