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