Manager / Sr.Manager Remediation

As a candidate for the mentioned role, you should possess a strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements. Your experience should include investigations related to complaints, product rejections, non-conformances, recalls, deviations, audits, and regulatory inspections. Additionally, you should have managed change management, quality risk management, and Corrective Action and Preventive Action System throughout the Product Lifecycle. Implementation and maintenance of an effective Quality Management System should also be part of your expertise. Key Responsibilities: - Establish a roadmap for the remediation activities. - Ensure timely resolution of issues/risks on remediation projects. - Facilitate preparation for Executive Steering Committee reviews. - Identify and list key activities for implementation, assign activity owners, and target completion dates. - Act as the point of contact and communicate remediation status adequately to all team members. - Review the completed remediation actions for their adequacy and ensure they meet the agreed commitment. - Ensure that key stakeholders are informed about relevant risks and assist in implementing remediation plans. - Demonstrate dynamism with good communication and leadership qualities. Qualification Required: - Educational Qualification: M.Sc / B.Pharm / M.Pharm - Location: Baroda - Experience: 15 to 18 years You should perform all work in line with Sun Pharma values of Humility, Integrity, Passion, and Innovation, as well as in accordance with all established regulatory, compliance, and safety requirements. As a candidate for the mentioned role, you should possess a strong understanding of GMP requirements, exposure to Regulatory Inspection, and knowledge of international GMP requirements. Your experience should include investigations related to complaints, product rejections, non-conformances, recalls, deviations, audits, and regulatory inspections. Additionally, you should have managed change management, quality risk management, and Corrective Action and Preventive Action System throughout the Product Lifecycle. Implementation and maintenance of an effective Quality Management System should also be part of your expertise. Key Responsibilities: - Establish a roadmap for the remediation activities. - Ensure timely resolution of issues/risks on remediation projects. - Facilitate preparation for Executive Steering Committee reviews. - Identify and list key activities for implementation, assign activity owners, and target completion dates. - Act as the point of contact and communicate remediation status adequately to all team members. - Review the completed remediation actions for their adequacy and ensure they meet the agreed commitment. - Ensure that key stakeholders are informed about relevant risks and assist in implementing remediation plans. - Demonstrate dynamism with good communication and leadership qualities. Qualification Required: - Educational Qualification: M.Sc / B.Pharm / M.Pharm - Location: Baroda - Experience: 15 to 18 years You should perform all work in line with Sun Pharma values of Humility, Integrity, Passion, and Innovation, as well as in accordance with all established regulatory, compliance, and safety requirements.