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    Quality Manager Pharma API industry - Bengaluru, India - Infinitalent Consulting (P) Ltd

    Infinitalent Consulting (P) Ltd
    Infinitalent Consulting (P) Ltd Bengaluru, India

    5 days ago

    Default job background
    Full time
    Description

    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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