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Senior Manager – Quality Assurance & Regulatory Affairs

15 years

0 Lacs

Posted:11 hours ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

Job Description Join a leading firm in the consulting sector, specializing in quality assurance and regulatory affairs services. This dynamic company operates within the regulatory landscape, guiding businesses in compliance with industry standards to enhance operational efficiency and product quality. Key Responsibilities Quality Assurance (QA): Set up and manage quality systems as per ISO and GMP standards. Lead internal and external quality audits. Oversee quality checks during product development, production, and release. Review important documents like SOPs and batch records. Work closely with production and R&D teams on quality testing and improvements. Manage deviations, CAPAs, and risk assessments. Regulatory Affairs (RA) Ensure product compliance with regulations in India and other countries (e.g., FDA, EU, BIS). Prepare and submit documents for product approvals and licenses. Stay updated on regulatory changes and advise the team. Check product labels and ingredients for regulatory compliance. Coordinate with government bodies and certification agencies. Keep proper documentation for audits and inspections. Team & Collaboration Lead and guide the QA and RA teams. Work with other departments like R&D, Manufacturing, and Marketing. Support product launches in new markets by managing approvals. Requirements Degree in Pharmacy, Cosmetic Technology, Chemistry, or related field. 10–15 years of experience in quality and regulatory roles in the cosmetic/skincare industry. Good knowledge of local and international cosmetic regulations. Strong leadership, communication, and organization skills. Experience handling audits, documentation, and compliance tasks. Preferred Experience with natural or organic skincare products. Certifications like ISO 22716 (GMP), ISO 9001. Knowledge of safety, microbiological, and toxicology testing. Skills: quality assurance,regulatory compliance,risk management,process improvement,audit management,root cause analysis,regulatory affairs,iso,compliance Show more Show less

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