Job Description

Job Summary:

• To perform Quality audits of contract manufacturing organizations, API, Packing Materials, Intermediates, Central Warehouse and Carry and Forwarding agents (both existing and new) to ensure that these sites/organizations are maintaining quality standards in compliance with cGMP standards in line with regulatory requirement as well as with Sun Pharma\'s Policy / SOP\'s.
• To maintain discontinuations, waivers and audit extensions of CMOs & Warehouses.

• Coordination and planning with CMO/C&F /Vendor for audit date through commercial.
• Preparation of yearly planner / monthly Audit Schedule
• To plan and execute Quality Audits as per corporate Quality audit schedule.
• Escalation of critical and important audit observation to the management.
• To prepare Audit report and share with respective site within stipulated time.
• Follow up for compliance report and adequate CAPA evidences against the audit observations and initiate the close out report
• Conduct \xe2\x80\x9cfor cause\xe2\x80\x9d and investigational audits of CMO\'s as required by organization.
• Preparation & submission of monthly report.
• Preparation of Departmental Guideline, SOPs.
• Assessment, Tracking and archival of Discontinuation, waiver and Extensions of CMO & C&F
• Trending of Audit Observations of CMO/ CWH /C&F.
• Ensure availability of audit records in Trackwise
• Knowledge enhancement in line with current GMP and regulatory guidelines / requirements.
• Support to other function of Corporate Quality Audit team as and when required.
• To participate and support project work as assigned.

• Masters in Science or Engineering, or PharmD.
• 10+ years of experience in Laboratory Control, Quality Assurance, Quality and compliance, validation and self-inspection/ audit in API/ Formulation pharma industry.
• Knowledge of GMP\'s in both domestic and international regulatory environments.
• Strong organizational, interpersonal and communication skills.
• Ability to work effectively in multicultural matrix organization

• 60% Travel (mostly U.S. Domestic, with rare occasional visits to Canada & Brazil)

Sun Pharmaceutical Industries