QA & RA Associate

1 day ago

Ahmedabad Gandhinagar, India Mantras2success Consultants Full time

Job Description Key Responsibilities: - Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS). - Conduct internal quality audits and participate in management review meetings. - Handle investigations of complaints and implement corrective and preventive actions. - Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in accordance with ISO 13485:2016. - Prepare technical files, including Instructions for Use (IFUs), labeling, packaging information, and patient information leaflets, as per EU MDR 2017/745. - Review certificates of analysis (COA), sterilization check sheets, calibration reports, and other relevant documents. - Oversee microbiology and quality control activities, including water testing, media preparation, and instrument operation. - Ensure compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory requirements. - Prepare and maintain site master files and device master files in compliance with Indian MDR. - Conduct training sessions on quality-related topics. - Stay updated on regulatory changes, including EU MDR requirements. - Assist in the preparation of clinical evaluation reports, risk management analyses, and other regulatory documents. - Review and update quality manuals, device master files, and other essential documents for compliance. Key Skills : - Documentation Executive - Qa - Regulatory Affair

  • QA, Qc

    1 week ago

    Ahmedabad, India Winston HR Services,Ahmedabad Full time

    We have multiple openings for a Pharma company at Vadaodara location QA Executive - 5 yrs exp. required QC Executive - 5 yrs exp. required RA Executive - 2 yrs exp. required Pay: ₹30,000.00 - ₹70,000.00 per month Schedule: - Day shift - Morning shift Ability to commute/relocate: - Vadodara, Gujarat: Reliably commute or planning to relocate before...

  • QA Associate

    3 days ago

    Gandhinagar, India Mantras2success Consultants Full time

    Job Description - Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements. - Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance. - Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists. - Participate in internal...

  • QA Ayurvedic

    2 weeks ago

    Ahmedabad, Gujarat, India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for QA Ayurvedic. **Education**: M.Sc /B. Pharm / M. Pharm **Experience**: 0 -2 Year Experience in Production. *Freshers can apply. **Industries**: Pharmaceutical Company **Job Location**: Santej Ahmedabad. **Responsibilities**: - Review the Batch records for completeness and compliance for batch release. - To prepare the...

  • Associate – ai/ml

    1 week ago

    Gandhinagar, India DRC Systems Full time

    Associate – AI/MLExperience – 2 yrs+Location : GIFT CITY, GandhinagarQualification : Bachelor’s or Master’s in Computer Science, AI, Data Science, or a related field.Shift :10:00 AM to 06:30 PMRequirementsDRC Systems is a forward-thinking technology company building next-generation digital and AI-powered solutions. We combine innovation, engineering...

  • Associate – ai/ml

    2 weeks ago

    Gandhinagar, India DRC Systems Full time

    Associate – AI/MLExperience – 2 yrs+Location : GIFT CITY, GandhinagarQualification : Bachelor’s or Master’s in Computer Science, AI, Data Science, or a related field.Shift :10:00 AM to 06:30 PMRequirementsDRC Systems is a forward-thinking technology company building next-generation digital and AI-powered solutions. We combine innovation, engineering...

  • Business Development Manager – International Markets

    6 days ago

    Ahmedabad, Gujarat, India Medipharma Konnect Full time ₹ 8,00,000 - ₹ 25,00,000 per year

    We are hiring a Business Development Manager International Markets to lead our pharmaceutical exports in semi-regulated and regulated markets. The role involves identifying new opportunities, developing country-specific market entry strategies, managing international clients, handling regulatory & commercial support, and driving revenue growth. The candidate...

  • Quality Assurance

    6 days ago

    Ahmedabad, Gujarat, India Zydus Group Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Company:Zydus Medtech Pvt LtdReporting:Zydus Medtech HeadLocation:AhmedabadKey ResponsibilitiesThe Lead of Quality Assurance and Regulatory Affairs will be a senior leadership role reporting directly to the BU Head. This position is responsible for the strategic direction, oversight, and execution of all Quality Assurance (QA) and Regulatory Affairs (RA)...

  • Data QA

    2 weeks ago

    Bodakdev, Ahmedabad, Gujarat, India X-Byte Enterprise Solutions Full time

    We, X-Byte are looking for Process Associate / Data QA Analyst. X-Byte was established in 2012. Offering custom data analysis solutions, web & Mobile App scraping services, Web & Mobile App Development, API Solutions, Data analytics & BI Solution to our customers of all sizes by using the latest technologies focused to help enterprises get huge scale...

  • QA Executive

    2 weeks ago

    Thaltej, Ahmedabad, Gujarat, India Smartway wellness pvt ltd Full time

    **Job Summary**: **Key Responsibilities**: - Coordinate with third-party manufacturing (TPM) and packaging sites to ensure adherence to company and regulatory quality standards. - Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs) from TPMs. - Monitor and support investigation of deviations, change controls, and CAPAs...

  • Regulatory Affairs Officer

    3 days ago

    Sola, Ahmedabad, Gujarat, India DF Pharmacy Full time

    **New Drug Development** **Responsibilities**: - Assist in research and development of new drug formulations. - Conduct pre-formulation and formulation studies. - Support analytical testing and stability studies. - Help in documentation and report preparation as per regulatory standards. - Coordinate with cross-functional teams like QA, QC, and RA during...