Job Title: Senior QA Analyst – Formulation Location: Cherlapally Department: Quality Assurance – Formulation Industry: Pharmaceutical Formulations / Manufacturing Employment Type: Full-Time Job Summary: We are looking for a highly skilled and experienced Senior QA Analyst – Formulation to join our Quality Assurance team. The candidate will be responsible for ensuring the highest standards of product quality, regulatory compliance, and documentation accuracy throughout the formulation and manufacturing lifecycle. The role also includes review and coordination of DMF (Drug Master File) related activities and documentation for domestic and international regulatory submissions. Key Responsibilities: Review and approval of Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs) . Ensure compliance with GMP, GLP, GDP , and company SOPs during all manufacturing and formulation processes. Conduct line clearance , in-process checks , and verification of documentation at each stage of formulation. Review analytical data, stability studies , validation protocols, and summary reports. Oversee and coordinate deviations, change controls, CAPA, OOS, and OOT investigations related to formulation batches. Review and maintain DMF (Drug Master File) , PDR , and technical documents in line with global regulatory requirements (USFDA, EU, WHO, MHRA, TGA, etc.). Prepare, review, and ensure timely submission of DMF updates , Annual Product Reviews (APR/PQR) , and other regulatory compliance documents. Coordinate with Regulatory Affairs , QC , R&D , and Production teams for smooth documentation flow and audit readiness. Participate in internal, external, and regulatory audits , ensuring corrective actions and compliance. Ensure data integrity, documentation accuracy, and record traceability across all QA activities. Provide training and support to QA team members on documentation, DMF preparation, and GMP compliance. Desired Candidate Profile: Qualification: B.Pharm / M.Pharm / M.Sc in Chemistry or related field. Experience: Minimum 5–8 years in Quality Assurance (Formulation) within a regulated pharmaceutical company. Expertise in: DMF preparation and review (USDMF, EDMF, CEP, etc.) Regulatory documentation and dossier preparation Handling deviations, CAPA, and change control systems Data integrity and compliance audits Good understanding of ICH, WHO, USFDA, and EU GMP guidelines. Excellent analytical, communication, and documentation skills. Job Type: Full-time Pay: ₹300,000.00 - ₹700,000.00 per year Work Location: In person
Job Title: HPLC Operator / Senior QC Analyst Location: Cherlapally, Hyderabad Employment Type: Full-time Department: Quality Control / Analytical Industry: Formulation About the Role We are seeking a highly skilled and dedicated HPLC Operator / QC Analyst to join our Quality Control team. The ideal candidate will be responsible for performing instrumental analysis using HPLC and other analytical techniques, ensuring that all activities are carried out in compliance with GMP, GLP, and data integrity standards . This position plays a vital role in supporting product quality, regulatory compliance, and analytical excellence within the organization. Key Responsibilities Analytical Testing & HPLC Operations Perform HPLC analysis for finished products, in-process samples, and stability batches as per approved methods. Responsible for entire HPLC operation and maintenance , including system suitability, column care, and data review. Conduct assay, related substances, dissolution, and impurity profiling for solid and liquid formulations. Execute analytical method validation, transfer, and verification according to ICH Q2 (R1) guidelines. Perform troubleshooting and preventive maintenance of HPLC and other analytical instruments (GC, UV, FTIR, etc.). Sample Handling & Preparation Prepare standard and sample solutions accurately as per SOPs and analytical procedures. Label, document, and store samples according to GMP and data integrity requirements. Documentation & Compliance Record and maintain analytical raw data, chromatograms, and results in compliance with Good Documentation Practices (GDP) . Ensure strict adherence to GMP, GLP, and ALCOA principles in all quality operations. Review analytical results and prepare COAs, analytical reports, and trend summaries . Participate in OOS/OOT investigations, deviations, and CAPA implementation with QA and QA-QC leads. Audit & Quality Support Support internal, customer, and regulatory audits (USFDA, MHRA, WHO, TGA, etc.) by providing analytical documentation and justifications. Assist in stability studies and periodic review of analytical data. Coordinate with cross-functional departments such as Production, QA, and R&D for analytical testing and method transfer. Qualifications & Experience B.Sc. / M.Sc. in Chemistry, Pharmaceutical Chemistry, or related discipline. 4-9 years of hands-on experience in HPLC operations within a pharmaceutical formulation unit . Proficiency in HPLC software such as Empower, Chromeleon, or OpenLab. Strong understanding of GMP, GLP, ICH, and regulatory requirements related to formulation testing. Ability to perform precise analysis and maintain data integrity. Preferred Skills Experience with stability testing, impurity profiling, and method validation for oral or sterile dosage forms. Knowledge of instrument calibration, equipment qualification (IQ/OQ/PQ) , and electronic data management systems. Exposure to regulatory audits and compliance documentation . Job Type: Full-time Pay: ₹300,000.00 - ₹800,000.00 per year Work Location: In person