Regulatory/Quality Assurance
6 days ago
Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). Participate in development of Regulatory Strategy for upcoming products against GSPR requirements. Participate in the development of QA strategies, recommendations for Continual improvement, Quality planning in conjunction with the needs of the company, for each product range and Quality Management System. Sustain and active Quality Management System, such as Management Review, Internal Audit, CAPAs, NCRs, Document Control, Change Control, Risk Management and Training. Participate and assist for establishment, verification, and implementation of Standard Operating Procedures to comply with a regulatory requirement. To maintain awareness of new legislation, policies, standards, and guidelines impacting Merlin’s products and Quality Management System. Update the relevant standard, regulatory guideline, and essential requirement. Participate and assist for regulatory submitting and reporting compliance with the requirements and relevant standard or guidance. Assist in the compliance of Validation/ Verification Program and Design and Engineering studies. Promote audit readiness, prepare Merlin’s team for audits by external bodies, including NB, FDA, and facilitate audits as needed. Interface with inspectors, and NB auditors during inspections and provide post-inspection follow-up information as requested. Manage day to day execution of the quality system, and quality assurance activities facilitate and implements improvements to the quality system while maintaining compliance with applicable Quality System Regulations and ISO standards. Secondary Job Responsibilities: Assist in the development and administration of department budgets, schedules, and other administrative functions. Support company goals and objectives, policies and procedures, QSR, and CE regulations. Regularly communicate Regulatory/ Quality and Project status to other department heads. Any other tasks or projects that are being assigned by the immediate supervisor, as and when required. Minimum Education Required: Bachelor’s degree in life sciences, engineering, or equivalent (life sciences post graduate, engineering, or equivalent with 10 years experiences) Additional Qualifications Required: ISO 13485, ISO14971, US FDA 21 CFR part 820 certification MDR 2017/745 Medical Device requirement certification Sterilization process certificate Biocompatibility of medical devices Certification Minimum Experience: Minimum 10 years of related experience in the medical device
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Quality Assurance Executive
4 weeks ago
Delhi, India Intrinseque Health Full timeJob Description The role will involve implementing and maintaining quality assurance standards, conducting quality inspections, and ensuring compliance with regulatory requirements. Day-to-day tasks will include reviewing and approving quality documentation, conducting audits, and collaborating with cross-functional teams to resolve quality...
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Regulatory/Quality Assurance
6 days ago
India Merlin MD Pte Ltd Full timeTips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21 CFR part 820). #...
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Regulatory/Quality Assurance
5 days ago
India Merlin MD Pte Ltd Full timeTips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21...
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Regulatory/Quality Assurance
7 days ago
India Merlin MD Pte Ltd Full timeTips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall. Responsibilities Participate in the implementation and maintenance of the management system compliance with relevant international quality standards and regulatory requirements (Such as ISO 13485, ISO 14971, MDR 2017/745, and 21...
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Quality Assurance Manager
4 weeks ago
Mumbai, India AMN Life Science Pvt. Ltd. Full timeJob Description Company Description AMN Life is a leading manufacturer and exporter of a wide range of formulations in various therapeutic segments including antibiotics, gastro, anti-inflammatories, cardiology, nephrology, CNS, and oncology. With facilities approved by EU, Health Canada, Brazil - Anvisa, and Philippines situated in Bhilad (Gujarat) and...
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Quality Assurance Regulatory Affairs Manager
4 weeks ago
Kolkata, India ELESONIC GROUP Full timeJob Description Company Description Elesonic Group, originally founded in 1965, has grown substantially since establishing its in-house X-ray machine manufacturing plant in 2006. Elesonic Healthcare Private Limited, based on the outskirts of Kolkata with a National Sales office in Central Kolkata, specializes in manufacturing medical equipment like X-ray...
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Quality Assurance Manager
4 weeks ago
Tumkur, Karnataka, India, Karnataka Alp Consulting Ltd. Full timeJob DescriptionDesignation: Quality Assurance Manager/Deputy ManagerQualification: M.Pharma/ B.Pharma /M.sc (in Chemistry/Biochemistry/Industrial etc)Desired Experience: 8 to 12 years experience in API/Pharmaceutical industry Employee Type: Full Time, PermanentLocation: Tumkur FactoryJob Responsibilities:To develop and implement a comprehensive quality...
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Quality Assurance Manager
1 day ago
Hyderabad, India Promea Therapeutics Full timeJob Description Job Responsibilities - To ensure Sit Ready for anytime Regulatory Inspection in Compliance to cGMP Norms of Various Regulatory Bodies. - To train personnel on cGMP, regulatory expectations, and quality systems to enhance compliance and awareness. - To ensure Vendor Qualification activities are conducted as per SOPs, and maintain an up-to-date...
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Officer - Quality Assurance
3 weeks ago
Pune, India Shalina Healthcare Full timeJob Description What you become a part of: The IPQA Officer/Executive will be responsible for ensuring in-process quality assurance activities across all manufacturing operations. The role involves monitoring compliance with SOPs, GMP standards, and regulatory requirements, along with reviewing documentation and supporting process validation. What to expect:...
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Design Quality Assurance
4 weeks ago
Pune, India Infosys Limited Full timeJob Description Responsibilities : Be a part of core project team and support the quality engineering across the entire development cycle Lead product risk management, usability, reliability and design validation efforts for new product development and design change projects. Lead the development and implementation of design verification and validation plans...
