Quality Manager Pharma API industry

1 month ago


Bengaluru, India Infinitalent Consulting (P) Ltd Full time

Position: Senior Manager - Quality

Reporting to : Managing Director

Work Location: Doddaballapur, Bangalore

Preferred; Pharma API industry


Qualifications and Skills


  • Minimum 12 to 15 years of experience in a similar role, preferably in the pharmaceutical or chemical manufacturing industry
  • Strong knowledge of quality management systems and regulatory requirements
  • Direct exposure to regulatory audits with examples of interactions (verbal and written) with auditors
  • Good communication skills ability to write clear reports (such as OOS, deviation investigation reports)
  • Teamwork Ability to work cross-functionally
  • Familiarity with CGMP manufacturing processes and requirements
  • Knowledge of Schedule M and CTD documents
  • Ability to investigate and prepare deviation investigation reports
  • Master's degree in Chemical Engineering or a related field
  • Excellent communication and leadership skills


Roles and Responsibilities


  • Develop and implement quality management systems (QMS) to ensure compliance with industry standards and regulations
  • Lead and manage a team of quality professionals to achieve company goals and objectives
  • Conduct regular audits to assess the effectiveness of quality control measures
  • Prepare responses to audit observations and communications to external parties related to QMSs
  • Interact with customers to satisfy their VQ requirements
  • Ensure adherence to Good Manufacturing Practices (GMP) and other applicable regulations
  • Interact with customers on any product quality issues
  • Prepare and submit CTD documents to regulators as required
  • Investigate and resolve deviations, non-conformities, and customer complaints
  • Collaborate with cross-functional teams to identify areas for process improvement
  • Provide training and guidance to employees on quality-related topics
  • Stay updated with industry trends and developments to implement best practices


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