Deputy General Manager/ Associate General Manager - Corporate Quality

RESPONSIBILITIES

• Review and approve change controls initiated by plants and send to CQA for approval.
• Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
• Organize and execute internal audits at all plants and corporate departments as per the annual planner.
• Ensure audit reports and compliance reports with CAPA plan are prepared and implemented.
• Monitor and ensure that all plants comply with cGMP, cGLP requirements and good documentation practices.
• Review and approve of CQA guidelines. Update the CQA guidelines in line with the regulatory requirement.
• Review and approve SOP of Corporate departments.
• Review and approve of change controls, deviations, protocols and reports, qualification documents, stability protocols and MPR of corporate departments.
• Support plants for the review of regulatory compliance report and customer quality agreements as per requirements.
• Ensure that detailed investigations are in place for out of specifications, market complaints, product recall, and stability failures and that appropriate CAPA is planned and executed as per the defined procedures.
• Ensure that all team members are trained and updated in line with regulatory requirements.

DESIRED SKILLS

• Should have adequate experience of facing various regulatory Inspections like USFDA, MHRA, EMA, TGA etc.
• Adequate experience of auditing finished dose formulation units, API and Intermediate/KSM vendors.
• Experience of working in Formulation unit as well as API unit would be preferred.
• Very good functional knowledge and application.
• Proactive approach to internal and external queries.
• Managing multiple stakeholders.
• Should hold high standards of business ethics.
• Excellent communication skills and decision-making skills.