Job Responsibilities: 1. Document analysis procedures and the test results mainly bioburden testing, spectrophotometric testing and mechanical studies using UTM machines 2. Document product stability studies are completed satisfactorily and supported by correct product sample analysis 3. Establish a tracking mechanism for customer & field complaints and suggest corrective actions Profile: 1. You have experience of around 3 or more years in pharmaceutical industry 2. Educational Qualification - M.Sc./M.Pharm degree with strong interest in quality control documentation 3. You work accurately, technically minded and able to work independently after training in the matter entrusted to you. Experience in a formulations/ API industry is an asset
1. Maintain the QMS documents on the lines of ISO 13485 and GMP 2. Responsible for control of all levels of documents & their history in accordance with EU MDR 3. Coach and Guide the team to support company goals by : Identifying factors that are critical to prospective and retrospective stability studies Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations
Background Industry: Pharmaceutical Formulations (Injectables) or Medical Devices (EU Class 2b or higher) manufacturing company with turnover higher than 300 Cr Required Skills: Experience in QA management across multiple projects involving the implementation of the Company's QA processes and strategies. The projects include IPQA, QMS, cGMP, validation and Compliance related assignments Ensure that the norms and laws, set by regulatory authorities, are met. Preferentially an audit experience for FDA, EU MDR, PMDA, SFDA, TGA and KFDA requirements Excellent knowledge of QA processes including of risk management, clinical data management and electronic data management systems. Ability to handle adverse events and rectify non conformities reported in inspections
Job Responsibilities: 1. Develop analytical methods on GC-HS, and GC-MS for fine chemicals and their impurities 2. Document analysis procedures and the test results mainly for wet labs and spectrophotometric testing 2. Document product stability studies are completed satisfactorily and supported by correct product sample analysis 3. Establish a tracking mechanism for customer & field complaints and suggest corrective actions Profile: 1. You have experience of around 3 or more years in pharmaceutical industry 2. Educational Qualification - M.Sc./M.Pharm degree with strong interest in quality control & its documentation 3. You work accurately, technically minded and able to work independently after training in the matter entrusted to you. Experience in an API industry is an asset
Caregroup Sight Solution Pvt. Ltd. is a leader in the global ophthalmic industry, specializing in the precision molding of engineering polymers and polyolefins to create advanced medical devices. Our commitment to innovation, quality, and high-end technology drives our mission to earn a significant place in medical devices industry. Job Summary We are seeking a highly motivated and detail-oriented Senior Executives in Plastic Molding Operations to join our team. The ideal candidate will have a solid understanding of plastic and polymer science and a keen interest in high-precision manufacturing. This role is crucial for ensuring the quality and efficiency of our molding operations and will provide an excellent opportunity for professional growth in the medical device sector. Key Responsibilities Molding Operations: Run and oversee high-precision plastic molding machines and related equipment. Process Development: Assist in the development and optimization of molding processes to improve efficiency, reduce waste, and enhance product quality. Operational Insight: Pay close attention to small but critical details in the molding process to identify and resolve potential issues. Quality & Compliance: Ensure all operations are in strict compliance with medical device regulatory standards (e.g., ISO, FDA). This includes documentation and adherence to quality control procedures. Maintenance: Perform regular routine maintenance and troubleshooting on molding machinery and auxiliary equipment to ensure continuous, uninterrupted production. Team Collaboration: Work closely with senior technicians and engineers to learn new processes and contribute to a safe and productive work environment. Qualifications Diploma in Plastic Technology or Diploma in Plastic Mold Technology from a recognized institution (e.g., CIPET). Strong theoretical and practical knowledge of plastic molding processes. Excellent attention to detail and problem-solving skills. Ability to follow complex instructions and maintain precise records. Familiarity with quality control systems and regulatory compliance is a plus. This is a fantastic opportunity for a dedicated individual to start a career in the high-growth, high-tech medical device industry.
About Us Care Groups operations involve the development and manufacturing of intraocular lenses and associated ophthalmic medical devices & ophthalmic pharmaceuticals. We are dedicated to leveraging cutting-edge technology and stringent quality standards to deliver innovative healthcare solutions globally, ultimately focusing on improving patient outcomes. Our operations demand a commitment to the highest international standards of quality and regulatory compliance. The Role: This role demands a strategic leader with deep technical expertise in medical device and/or pharmaceutical regulations, particularly concerning implantable medical devices or sterile injectable formulations . You will be the primary liaison with global regulatory bodies, CDSCO and lead our compliance efforts across domestic and key international markets. Key Responsibilities: Global Regulatory Strategy & Submissions: Develop and implement effective regulatory strategies for new and existing implantable medical devices and/or injectable formulations across key global markets. Oversee the preparation, compilation, and submission of regulatory dossiers (CTD/eCTD, Technical Files, and Design Dossiers) to global health authorities. International Regulatory Expertise (Mandatory): Ensure rigorous adherence to diverse global regulatory frameworks, including EU- MDR, PMDA and MDSAP member markets Agency Liaison & Inspections: Establish and maintain strong working relationships with regulatory agencies (e.g., EU Notified Bodies, PMDA, KFDA, TGA, etc.). Act as the primary lead for all external regulatory inspections and audits, managing responses and follow-up actions. Regulatory Intelligence & Policy : Monitor and interpret evolving global regulatory landscapes and standards (e.g., ISO 13485:2016, ISO 14971). Translate new requirements into actionable internal policies and procedures in collaboration with the QA team. Post-Market Surveillance & Vigilance: Ensure timely execution of robust post-market surveillance (PMS) activities, clinical performance reports (GSPR), vigilance reporting, and Materiovigilance in compliance with global standards. Risk Management Oversight: Provide regulatory leadership and final approval on product and compliance risk assessments (ISO 14971), ensuring identified risks are acceptable to relevant regulatory bodies. Required Qualifications & Experience Experience: A minimum of 8+ years of progressive experience in Regulatory Affairs within the medical device or pharmaceutical/sterile formulations industry is essential, with at least 3 years in a leadership role. Specialized Product Experience: Prior hands-on experience with implantable medical devices or sterile injectable/ophthalmic formulations is mandatory. Regulatory Acumen: A proven track record of successful multi-country regulatory submissions and approvals involving the listed global frameworks (MDR, MDSAP, PMDA, KFDA, TGA). Education: Masters degree in a relevant scientific, or regulatory discipline. Skills: Excellent leadership, strategic thinking, and negotiation skills. Ability to manage complex projects and communicate effectively with global health authorities and internal stakeholders.
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