1. Accountable for accepting audit assignments, performing audit pre-work, conducting audits and ensuring post audit activities are completed within defined timeframes.
2.The position requires negotiating with external firms to attain acceptable corrective actions and independent generation of extensive, high quality, Good Manufacturing Practice (GMP) documentation, as well as extensive communication and partnership with divisional oversight groups and commercial sites.
3.Schedule and perform assigned audits and ensure timelines for audit steps (pre-work, conducting audit, issuance of audit report, CAPA receipt) meet established expectations.
4.Maintain a broad-based expertise of cGMP, our Company Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry including, but not limited to Biologics, Medical Devices, Small Molecules, Combination Products, APIs and Controlled Substances.
5.Obtain and maintain cutting-edge knowledge, application, and certification for various technical/Quality auditing topics
6.Maintain awareness of evolving industry and regulatory trends/regulations. 7.Support New Business opportunities through Due Diligence (electronic due diligence as well as on-site visits) and Pre- Contract Audits, issuance of reports, and evaluation of corrective and preventive actions.
8.Assist with preparation of annual audit schedule, using risk-based approaches for auditor assignment
9.Lead & Coordinate with Procurement and impacted Site Quality on critical audit findings and or audit refusals. Generate comprehensive presentations/summary of issues for effective communication to all levels, ensuring that the required assessments are performed.
10.Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet using site, management and regulatory expectations

Education Minimum Requirement:
• Hold a degree level qualification in Science, Chemistry, (Micro-) Biology, Engineering (or equivalent).

Required Experience and Skills:
• Experience of performing internal and/or external GMP audits in manufacturing, technology, and/or quality operation within EU/FDA, API, Drug Product, Medical Device or equivalent environment.
• Possess “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas; Medical Device/Combination product, Biologics, Vaccines, or SterileDrug Product manufacture.
• Quality/compliance experience in an EU/FDA regulated industry. Thorough understanding of Quality Management Systems and process to support the manufacturing of API’s, drugs products, and medical devices, including risk management.
• Strong compliance knowledge and proficiency in interpreting and applying regulatory requirements and guidelines.
• Ability to work independently with limited supervision in a virtual-management environment.
• Excellent/accomplished communication, negotiation, facilitation, influencing, and strategic thinking skills at all levels of organization.
• Be a positive change agent and able to adapt in a dynamic environment.
• Ability to travel globally approximately 50% of the time, both domestic and internationally.
• Hold a clean driver’s license.

Preferred Experience and Skills:
• Prior experience at a health authority performing GMP inspections.
• Demonstrated ability to lead and drive results/impact for critical business / compliance initiatives.
• Lean six-sigma belt / demonstrated process improvement experience.
• Knowledge of Quality by Design development & submission requirements.
• Experience with development, implementation and optimization of IT tools to deliver business outcomes/impact.

SHRIJI PHARMA LIMITED

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