HPLC and GC Analyst (method Validation) AURIGA RESEARCH PVT LTD

2.0 - 4.0 years

2 - 6 Lacs

Bengaluru

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Role & responsibilities 1. Knowledge of calibration and operation of HPLC with empower software. 2. Sound knowledge of analytical method development and Analytical method validation of OVI, purity, and assay method by HPLC as per pharma guidelines. 3. Knowledge of caliberation and operations of all equipments like balance, ph meter, in analytical opeartion. 4. good knowledge of sample preperation as per GLP. 5. Knowledge of retreival and storage working standards and columns. 6. Handling of final compilation of raw data, chromatographic data complying with GLP requirements. 7. Recording all analytical activities, approximately in respective raw data forms. 8. knowledge of preperation of general lab SOPs and instrument sops. Desired candidate profile: 1. Must have worked in method validation, ADL, analytical lab. 2, Knowledge of HPLC,

Posted 3 weeks ago

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HPLC Analyst (method Validation/development) Auriga Research

2.0 - 6.0 years

2 - 6 Lacs

Gurugram, Manesar

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Posted 3 weeks ago

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Senior Executive-QC Piramal Finance

2.0 - 6.0 years

4 - 8 Lacs

Navi Mumbai

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Job Overview To lead and execute analytical method validation, transfer, and verification activities in compliance with regulatory and cGMP standards, ensuring robust analytical support for product development, regulatory submissions, and commercial manufacturing. Competencies Plan, perform, and document Analytical Method Validation (AMV) and Analytical Method Transfer (AMT) for raw materials, intermediates, and finished drug products. Prepare and review protocols and reports related to method validation/verification/transfer in alignment with ICH guidelines. Coordinate with R&D, AR&D, QA, RA, and manufacturing units for method transfer and troubleshooting activities. Perform routine and non-routine analysis using HPLC, UPLC, GC, UV, IR, dissolution apparatus, and other analytical instruments. Ensure timely qualification/calibration of instruments used in AMV lab. Review analytical documents like raw data, chromatograms, validation reports, SOPs, etc. Support regulatory inspections (USFDA, EU, ANVISA, WHO, etc.) and respond to queries related to AMV/AMT. Investigate OOS/OOT/Deviation/Incident related to AMV activities and provide effective CAPA. Maintain GLP and cGMP compliance across AMV operations. Experience: 4 -5 years in QC-AMV in a regulated pharmaceutical environment Responsibilities Qualifications M.Sc. (Chemistry/Analytical Chemistry) / M.Pharm

Posted 1 month ago

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Sr. Officer/Executive Zuventus Healthcare Limited

5.0 - 10.0 years

6 - 8 Lacs

Sikkim

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Hands-on experience in - Perform the Analytical Method Validation by HPLC/GC Preparation and review of AMV Protocol and Reports Operations and calibration of the instruments like HPLC, GC etc. Preferred candidate - Having 5 - 10 yrs of experience in Quality control and must have at least 2 years in AMV

Posted 2 months ago

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Assistant Qc Manager Avantika Medex

8 - 12 years

6 - 9 Lacs

Ahmedabad

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Company Overview: We are a reputed pharmaceutical company specializing in the manufacturing of Oral Solid Dosage (OSD) formulations. Committed to high-quality standards and regulatory compliance, we are looking for a dynamic and experienced professional to join our Quality Control team. Job Purpose: The Assistant Manager Quality Control will oversee and manage day-to-day QC operations to ensure compliance with cGMP, GLP, and regulatory requirements for OSD manufacturing. This role is critical for maintaining product quality and supporting internal and external audits. Key Responsibilities: Supervise and lead a team of QC analysts and chemists in routine testing of raw materials, in-process samples, finished products, and stability samples. Review and approve analytical data, reports, and documentation in compliance with regulatory standards (USFDA, MHRA, EU, etc.). Ensure adherence to SOPs and perform periodic reviews and updates of QC procedures. Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory incidents, and implement CAPA. Coordinate and support analytical method validation, method transfer, and instrumentation qualification. Maintain and calibrate laboratory instruments such as HPLC, GC, UV, IR, and Dissolution testers. Assist in audit readiness and participate in regulatory and customer audits. Maintain LIMS or other data management systems effectively. Prepare and deliver periodic training sessions for QC staff. Desired Candidate Profile: Education: M.Sc. (Chemistry), B.Pharm, or M.Pharm Experience: 6–10 years in Quality Control within a regulated OSD manufacturing environment Skills: Hands-on experience with HPLC, GC, and other analytical instruments Sound understanding of cGMP, GLP, ICH guidelines Good documentation and review skills Proficiency in handling OOS/OOT and deviations Strong communication, leadership, and team management abilities Why Join Us? Opportunity to work in a growing, globally compliant pharma facility Competitive salary and performance-based incentives Strong focus on career development and technical training

Posted 2 months ago

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