Regulatory/Quality Assurance
7 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 certification MDR 2017/745 Medical Device requirement certification Sterilization process certificate Biocompatibility of medical devices CertificationMinimum Experience:Minimum 10years of related experience in the medical device
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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...
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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...
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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...
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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**...
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Quality Assurance Executive
3 weeks ago
New Delhi, India Illusion Dental Laboratory Full timeJob Title: Quality Assurance Executive No of Vacancy: 1 Job Location: Kochi Years of Experience:1-4 years Working Days: Monday to SaturdayJob Purpose: We are looking for a detail-oriented and committedQuality Assurance Executiveto support and enhance ourQuality Management System (QMS)in compliance withISO 13485 ,21 CFR Part 820 , and other applicable...
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Quality Assurance
20 hours ago
Delhi, Delhi, India Varun Chandra Development and Construction LLP Full time ₹ 2,16,000 - ₹ 3,60,000 per yearQuality Assurance (QA) Responsibilities:Develop, implement, and maintain quality assurance processes to ensure compliance with industry standards, company policies, and regulatory requirements.Conduct audits and inspections to assess compliance with established quality standards.Collaborate with cross-functional teams, including production, engineering, and...
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Quality Assurance Manager
3 weeks ago
New Delhi, India Rollick Ice Cream Full timeAbout the CompanyEstablished in 1989, Rollick is today, amongst the largest manufacturers of frozen dessert in Eastern India, with state of the art manufacturing units in Kolkata. It has a fast growing network of over 500 distributors across the region. Rollick’s product range includes a variety of ready to eat cups, sticks, cones, take home tubs and bulk...
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Quality Assurance Manager
5 days ago
New Delhi, India Isha LIFE Full timeDear Candidate,We have a requirement for Vendor Quality Assurance Executive for Isha Life, Coimbatore.This role ensures that all suppliers meet the company’s quality, safety, and compliance standards. The position involves evaluating vendors, managing quality documentation, coordinating material testing, and supporting cross-functional teams to maintain...
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Quality Assurance Manager
1 week ago
New Delhi, India Rollick Ice Cream Full timeAbout the CompanyEstablished in 1989, Rollick is today, amongst the largest manufacturers of frozen dessert in Eastern India, with state of the art manufacturing units in Kolkata. It has a fast growing network of over 500 distributors across the region. Rollick’s product range includes a variety of ready to eat cups, sticks, cones, take home tubs and bulk...
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Quality Assurance
3 weeks ago
New Delhi, India Jupiter AI Labs Full timeAbout the Role:We are looking for an experienced Quality Assurance Consultant to oversee quality checks for product batches before export. The role involves close coordination with accredited labs, suppliers, and internal teams to ensure compliance with quality standards and regulatory requirements.Key Responsibilities:- Coordinate with NABL-accredited...
