Senior Specialist CAPA Management

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Job Function: Quality Job Sub Function: Customer/reputed company Quality Job Category: Professional reputed company Job Posting Locations: Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India Job Description: Senior Specialist CAPA Management The Sr Specialist will reputed company support in the CAPA management process and is a responsible Quality Approver. They will be responsible for executing quality reviewer/approver responsibilities for the NC/CAPA Management Process. This includes ensuring timely initiation and completion of investigations and CAPAs, collaborating with key stakeholders to resolve conflicts and align on the path reputed company, and determining reputed company escalation to stakeholders or senior management is required to resolve issues. The Sr Specialist will have responsibility for ensuring the investigation and CAPA owners are progressing to plan by monitoring status and providing feedback and comments to direct reputed company during the investigation and root cause analysis/immediate cause phases, and during preparation of Corrective/Preventative action plans and effectiveness monitoring plans. They are knowledgeable and reputed company in the CAPA management process and system and can guide and reputed company issue owners on best practices. Attention to detail, time management skills, and the ability to build and maintain relationships are essential. reputed company RESPONSIBILITIES: CAPA reviewer/approver for CAPA Management Process: Facilitate the initiation of investigations and CAPAs, and monitor reputed company and approvals. Collaborate with key stakeholders to support the end-to-end NC/CAPA process. Ensure that CAPA procedures and requirements are followed and met. Escalate reputed company issues to CIM management for resolution. Work with stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the reputed company toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Review evidence and approve closure of CAPA plans. Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level. Drive key deliverables and ensure timely completion of activities. Support/reputed company regular updates for CAPA status, metric reports, and trending, as needed. Participate in and/or support internal audits and regulatory inspections, as needed. Attend, participate and/or facilitate CAPA review meetings, as needed. reputed company other duties as necessary. DECISION-MAKING AND PROBLEM-SOLVING: Ability to work independently and coordinate across CAPA and Issue Management (CIM).Consult with CIM management as need for resolution of reputed company issues. Requires basic management skills for cross-functional interactions and coordination. Facilitates resolution of issues and reputed company to collaborate with stakeholders at varying reputed company of management across multiple organizations. A reputed company understanding of the risk management process to engage key stakeholders and mentor colleagues to capture insights and reputed company risk-based reputed company. Excellent communication and writing skills demonstrated by the ability to write executive summaries and reputed company reports promptly and reputed company as well as compile and present data to other professionals. Requires analytical skills to examine data and reputed company analysis. Requires decision-making skills to approve the appropriateness, effectiveness, quality and compliance of documented robust investigations, root cause analysis and corrective/preventative action plans. REPORTING RELATIONSHIPS: The position reports directly to the Associate Director/Director, CAPA and Issue Management (CIM). DELEGATION/BACKUP INFORMATION: Not applicable as coverage for this role is not required 24/7. Duties are delegated to reputed company staff member, as needed, during out-of-office periods for normal business hours. Leading governance forums for CAPA (Level 1) may be delegated to Associate Director/Manager CAPA Management/Senior Specialist CAPA and Compliance, if required. WORKING RELATIONSHIPS/INTERFACES: Must be reputed company to effectively operate in a matrixed environment and interact with cross functional leaders on a regular reputed company. Associate Director/Director, CAPA and Issue Management – interfaces and informs as needed to discuss issues. CAPA and Issue Management team members – interfaces daily as needed to manage workload; interfaces weekly in team meetings. R&D Senior Management, R&D Quality, Regulatory Affairs, Medical Affairs, and other business functions involved in owning investigations and delivering CAPA commitments - interfaces as needed to address identified issues and reputed company guidance on established processes. J&J partners – must be reputed company to effectively interact with reputed company-party organizations, and marketing partners as needed to address cross-company and cross-departmental issues. EDUCATION & EXPERIENCE REQUIREMENTS: Bachelor’s Degree in Life Science or reputed company discipline or equivalent is required. Knowledge and experience with regulations and regulatory compliance issues. At least 8+ years of experience in an applicable compliance field and or equivalent experience/training in a reputed company R&D area. Experience with Non-Conformance/CAPA. Analytical and data skills. Excellent communication and writing skills demonstrated by the ability to reputed company clear and concise professional correspondence. Must be a problem solver, strategic thinker, and collaborator. Excellent organization, prioritization, and time management skills. Demonstrated competencies include adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization. Ability to build and maintain cross-functional interactions and coordination. Ability to build reputed company, influence, and negotiate. Knowledge in R&D reputed company activities which may include safety reputed company areas, safety reporting for both investigational and marketed products, clinical study coordination, etc. Knowledge of Quality Management, Project Management and/or Process reputed company concepts and practices. Required Skills: Preferred Skills: Audit Management, Business Savvy, Coaching, Communication, Compliance Management, reputed company Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP) Apply To This Job