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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Mumbai, India
Job Description:
Overall purpose of job: Plan, execute and manage quality assurance & quality systems and activities including maintaining GMP, GDP component, Process & Product Inspection and Release, CAPA/Non-conformances, Complaint Management, Distributor Management, Document Control and Training Systems, ensuring compliance with regulatory and company requirements. Key responsibilities: • Organize, plan and lead the execution and compliance related to Distributor Management with proficiency in using the associated records. • Knowledge and understanding of MDR 2017 and D&C Act 1940 & Rules 1945’ Legal Metrology. • Organize, plan and lead the execution and compliance related to quality system elements like Change control,Artwork Management, Complaint Management. • Effectively use the quality tools such as ECM, TruVault, Trackwise, SUMMIT, Windchill, EtQ etc. • Execute / Support activities related to internal and supplier/distributor audits to ensure compliance with regulatory requirements, company and international standards. • Organize, plan, lead and manage quality-related projects in alignment with Organization goals, as and when assigned. • Support activities related to document control, CAPA, NCR systems and processes. Shall actively participate in investigating the issues and document and follow up the action plans. Reviews report findings and makes recommendations for corrective action. • Execute and assist on Repack Relabel activities at FTWZ (Free Trade Warehousing Zone). • Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections, internal and supplier’s audits as well as corporate audits and coordinate responses. • Attend applicable training sessions as well as complete mandatory trainings in on-line Learning Management Systems (SUMMIT; CW) and retain all training records. • Management Report Preparation (Monthly Reports).
Required Qualification- • Bachelors &/or master’s degree in science, Graduate in Biomedical Engineering or equivalent is required. Must have at least 5 – 7 years’ experience in Pharm/Medical device industry. • Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint and Outlook. Core Competencies- • Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware – Applicable for JDs across all functions. • Attend applicable training sessions as well as complete mandatory on-line trainings and submit training records to the supervisor / franchise secretary and work as per the applicable SOPs and guidelines. Job location: Mumbai, India
**Required Skills: **
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing