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
