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.ResponsibilitiesParticipate 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 10years experiences)Additional Qualifications Required:ISO 13485, ISO14971, US FDA 21 CFR part 820 certificationMDR 2017/745 Medical Device requirement certificationSterilization process certificateBiocompatibility of medical devices CertificationMinimum Experience:Minimum 10years of related experience in the medical device
-
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...
-
Quality Assurance Executive
3 hours ago
Delhi, Delhi, India Oh Deli Full time ₹ 6,00,000 - ₹ 12,00,000 per yearRole DescriptionThis is a full-time on-site role for a Quality Assurance Executive located in Delhi, India. The Quality Assurance Executive will be responsible for overseeing quality control processes, ensuring compliance with quality standards, conducting quality audits, and managing quality assurance systems. The role involves routine inspections, testing...
-
Regulatory/Quality Assurance
7 days ago
Delhi, 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.ResponsibilitiesParticipate 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...
-
Quality Assurance Manager
4 weeks ago
New Delhi, India 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 industryEmployee Type: Full Time, PermanentLocation: Tumkur FactoryJob Responsibilities:- To develop and implement a comprehensive quality...
-
Quality Assurance Manager
3 weeks ago
New Delhi, India Alp Consulting Ltd. Full timeJob Description Designation:Quality Assurance Manager/Deputy Manager Qualification: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, Permanent Location: Tumkur Factory Job Responsibilities: To develop and implement a comprehensive quality...
-
Quality Assurance Manager
4 weeks ago
New Delhi, India AMN Life Science Pvt. Ltd. Full timeCompany DescriptionAMN 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 Kala Amb (Himachal...
-
Quality Assurance Officer
1 week ago
Delhi, Delhi, India Dhampur Green Full time**Quality Assurance Officer - Certification & Regulatory Compliance** **Job Purpose** To manage and ensure compliance / documentation with all food safety, quality, and regulatory standards by obtaining, maintaining, and renewing certifications including **FSSAI, Halal, Kosher, Non-GMO, RSPO**, and others as required by the business or market. This role...
-
Corporate Quality Assurance Associate
2 weeks ago
New Delhi, India Soterius Full time**Job** Location**: New Delhi, India **Requirements**: - At least 2 years of experience in quality assurance in GCP, preferably pharmacovigilance, in the CRO or pharmaceutical industry - Awareness of global regulatory and pharmacovigilance environment - Strong written and verbal communication skills - Willingness to work from job location **Job**...
-
Quality Assurance Engineer
1 week ago
Delhi, Delhi, India Madhu Instruments Pvt Ltd Full time ₹ 2,00,000 - ₹ 6,00,000 per yearUrgent Job opening for Quality Assurance ExecutiveResponsibilities· To handle all activities related quality management system, Quality Assurance & regulatory affairs for ISO 9001& 13485, 93/42/EEC Directive including-· Technical files making & updating including risk management, clinical evaluation, post market surveillance,quality plan, ESRs, etc.·...
-
Regulatory/Quality Assurance
6 days ago
New Delhi, 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.ResponsibilitiesParticipate 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...
