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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Manufacturing |
| Functional Area | Quality (QA-QC),Bio Tech / R&D / Scientist |
| EmploymentType | Full-time |
*Job Overview: Responsible for all Labeling components of Piramal Critical Care Products Worldwide with adherence to the labeling processes to ensure compliance with innovator labeling, internal company, external partners and GMP standards and specifications. Will participate in a cross-functional team environment as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations.Essential Duties and Responsibilities Ensures all Global labeling details (labels, cartons, package inserts, patient package inserts) required are accurate and compliant by managing evaluations, maintenance, reviews and approvals with cross-functional teams for regulatory submissions. Prioritized labeling updates, in collaboration with Regulatory Affairs, Supply Chain Management, Sales and other internal stakeholders Oversees and coordinates EU linguistic review process as appropriate Conducts Text comparison (originator, reference vs generic) Meets defined targets on productivity, quality and compliance, as set by and overseen by management Works with the Regulatory Affairs Strategist on planning, managing and implementing labeling updates Manages required labeling updates, proofreading, version control and quality control over entire labeling process Proofreads all types of label copy/annotation/etc. at all development stages as well as final label copy to ensure accuracy of labeling. Monitors and processes innovator labeling updates for existing generic products and ensure compliance with innovator updates, including side by side comparison with RLDs. Coordinates CCDS development and updates of PCC products and coordination of local labeling updates. Contributes to the development and/or review of all labeling aspects included in Promotional Material. Maintains all RA tracking tools, databases, and central repositories for labeling components.Key Competencies (knowledge, skills and abilities every person must possess to be successful) Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers Excellent verbal and written communication skills Knowledge of document control procedures Quality review for standard operating procedures Knowledge of global regulatory filings preferred Experience with filing requirements for EU Centralized, MRP and DCP procedures Medical device experience a plus Intermediate skills in Microsoft Office, particularly Excel and Word, *BS/MS Degree in a science or related field Minimum of 2-5 years experience in a regulated industry; pharmaceutical quality assurance or regulatory affairs experience highly desired Good Manufacturing Practice (GMP) knowledge required
Keyskills :
gmpcompilationvalidationprotocolsscmpharmaceutical quality assurancesupply chaincritical careversion controlchange requestspackage insertsmicrosoft officedocument controlregulatory affairs