Location : SVK PHARMA PVT LTD Industry : Pharmaceutical Manufacturing – Formulations Experience: 5–6 years (minimum) in QA for formulations We are looking for a technically strong and process-driven QA professional to join our team. The ideal candidate will have deep experience in pharmaceutical formulations and a solid track record in executing and managing quality systems, compliance activities, and documentation in line with international regulatory requirements. ✅ Key Responsibilities: Preparation and review of Batch Manufacturing Records (BMRs) and speciation documents for all product types. Authoring, reviewing, and controlling Standard Operating Procedures (SOPs) as per GMP and regulatory standards.Execution and management of Change Control procedures in alignment with QMS.End-to-end experience in:Drug Master File (DMF) documentationMethod Validation and Analytical TransferTMF (Technical Manufacturing File)Annual Product Quality Review (APQR)Preventive Maintenance coordination and compliance reviewManaging deviations, OOS/OOT, CAPAs, and risk assessments.Support for internal and external audits (regulatory and customer).Training junior QA staff and promoting quality culture on the shop floor.Collaboration with cross-functional departments: Production, QC, Engineering, RA. Ideal Candidate: Minimum 5–6 years of QA experience in pharmaceutical formulations (solid orals/injectables). Strong practical knowledge in:BMR review & speciation documentationSOP writing and controlChange Control systems and deviation handlingGMP, ICH, QMSExcellent understanding of regulatory expectations (USFDA, MHRA, WHO, etc.). Effective communicator with a proactive and quality-focused mindset. Education: B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent in a related field. Job Type: Full-time Pay: ₹60,000.00 - ₹200,000.00 per month Work Location: In person
Location : SVK PHARMA PVT LTD Industry : Pharmaceutical Manufacturing – Formulations Experience: 5–6 years (minimum) in QA for formulations We are looking for a technically strong and process-driven QA professional to join our team. The ideal candidate will have deep experience in pharmaceutical formulations and a solid track record in executing and managing quality systems, compliance activities, and documentation in line with international regulatory requirements. ✅ Key Responsibilities: Preparation and review of Batch Manufacturing Records (BMRs) and speciation documents for all product types. Authoring, reviewing, and controlling Standard Operating Procedures (SOPs) as per GMP and regulatory standards.Execution and management of Change Control procedures in alignment with QMS.End-to-end experience in:Drug Master File (DMF) documentationMethod Validation and Analytical TransferTMF (Technical Manufacturing File)Annual Product Quality Review (APQR)Preventive Maintenance coordination and compliance reviewManaging deviations, OOS/OOT, CAPAs, and risk assessments.Support for internal and external audits (regulatory and customer).Training junior QA staff and promoting quality culture on the shop floor.Collaboration with cross-functional departments: Production, QC, Engineering, RA. Ideal Candidate: Minimum 5–6 years of QA experience in pharmaceutical formulations (solid orals/injectables). Strong practical knowledge in:BMR review & speciation documentationSOP writing and controlChange Control systems and deviation handlingGMP, ICH, QMSExcellent understanding of regulatory expectations (USFDA, MHRA, WHO, etc.). Effective communicator with a proactive and quality-focused mindset. Education: B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent in a related field. Job Type: Full-time Pay: ₹60,000.00 - ₹200,000.00 per month Work Location: In person
Job Title: Senior QC Chemist / HPLC Operator – Formulations Company: SVK Pharma Pvt. Ltd. Location: Cherlapally Department: Quality Control – Formulations Employment Type: Full-Time Job Summary: We are seeking an experienced Senior QC Chemist / HPLC Operator to join our Formulation Unit . The candidate will be responsible for performing routine and non-routine analysis of finished products, in-process samples, and raw materials using HPLC and other analytical instruments in compliance with cGMP and regulatory requirements. Key Responsibilities: Perform analysis of raw materials, in-process, and finished products as per specifications. Operate, calibrate, and maintain analytical instruments such as HPLC, UV, Dissolution Apparatus, pH meter, and Balance . Conduct method validation, stability, and assay testing. Ensure proper documentation as per Good Laboratory Practices (GLP) . Prepare analytical reports and maintain control samples and records. Review analytical data and ensure timely completion of testing activities. Coordinate with QA and Production teams for sample management and issue resolution. Follow cGMP, GDP, and safety protocols within the laboratory. Qualifications and Experience: B.Pharm / M.Pharm / M.Sc (Chemistry) or related discipline. 3–6 years of experience in Quality Control (Formulation Unit) . Hands-on experience in HPLC operation, calibration, and troubleshooting . Knowledge of analytical method validation and regulatory guidelines (ICH, WHO, USFDA) preferred. Good communication, documentation, and team coordination skills. Job Type: Full-time Pay: ₹19,113.79 - ₹41,263.19 per month Work Location: In person
Job Title: Senior QA Executive – Formulations Department: Quality Assurance Location: Cherlapally,Hyderabad Experience: 4–8 years (Formulation QA) Qualification: B.Pharm / M.Pharm/Msc Chemistry Industry: Pharmaceutical Formulations (Pellets) Job Summary: We are seeking a highly skilled and detail-oriented Senior Quality Assurance Executive with strong experience in pharmaceutical formulations . The candidate will be responsible for implementing, reviewing, and maintaining quality systems, documentation, and regulatory compliance activities , ensuring adherence to cGMP and international regulatory standards . Key Responsibilities:1. Documentation & Compliance Preparation, review, and control of Standard Operating Procedures (SOPs) , Specifications , and Master Formula Records (MFRs) . Preparation and review of Certificate of Analysis (COA) and Method of Analysis (MOA) for raw materials, intermediates, and finished products. Preparation and maintenance of Validation Protocols and Reports (VQ/IQ/OQ/PQ) for equipment and utilities. Review and approval of batch manufacturing records (BMR/BPR) and ensuring GMP compliance. Preparation and review of water system reports (RO, Purified, and WFI), environmental monitoring records , and microbiological data . Preparation and submission of Drug Master File (DMF) and supporting technical documentation for regulatory submissions. Review and approval of change controls, deviations, OOS/OOT, CAPA , and risk assessments . 2. Validation & Qualification Support in process validation , cleaning validation , and equipment qualification . Preparation of validation master plan, protocols, and summary reports. Coordination with Engineering and Production teams for execution of validation activities. 3. Quality Systems & Audits Ensure compliance with GMP, GLP, GDP, and ISO standards . Participate in internal audits , vendor audits , and regulatory inspections (USFDA, MHRA, WHO, TGA, etc.). Review and monitor implementation of corrective and preventive actions (CAPA) post audits. Maintain and improve quality metrics and documentation control systems . 4. Training & Continuous Improvement Conduct periodic training on SOPs, cGMP, GDP, and documentation practices . Support continuous improvement initiatives in QA processes and quality systems. Liaise with cross-functional departments (Production, QC, Regulatory Affairs, Engineering, R&D). Job Type: Full-time Pay: ₹300,000.00 - ₹700,000.00 per year Work Location: In person
Job Title: Senior QC Executive – Formulations Department: Senior Quality Control (QC) Location: Cherlapally Experience: 4–8 years (in QC – Formulations) Qualification: B.Pharm / M.Pharm / M.Sc (Analytical Chemistry preferred) Industry: Pharmaceutical Formulations (Pellets) Job Summary: We are looking for a skilled and experienced Senior QC Executive – Formulations to manage analytical testing and validation activities in the Quality Control department. The candidate should have hands-on experience in HPLC, UV spectrophotometry, analytical method validation, and routine quality control testing for pharmaceutical formulations. Key Responsibilities:1. Analytical Operations Perform routine and stability analysis of finished products and raw materials using HPLC, UV, and other analytical instruments . Handle HPLC instrument calibration, troubleshooting, and maintenance . Prepare and review analytical test reports, chromatograms, and related documentation . Conduct assay, dissolution, related substances, and content uniformity tests. 2. Method Development & Validation Support analytical method development, transfer, and validation as per ICH guidelines. Prepare and execute method validation protocols and reports . Evaluate analytical data for accuracy, precision, and compliance with specifications. 3. Documentation & Compliance Prepare and review SOPs, STPs, and specifications related to QC activities. Ensure compliance with cGMP , GLP , and data integrity requirements. Maintain proper laboratory documentation and instrument logbooks . Participate in OOS/OOT investigations and implement CAPA where necessary. 4. Instrument Handling & Calibration Operate and maintain analytical instruments like HPLC, UV, FTIR, pH meter, dissolution tester, balance, and KF titrator . Ensure timely instrument qualification (IQ/OQ/PQ) and calibration activities. Coordinate with service engineers for preventive maintenance and troubleshooting. 5. Quality System & Audits Participate in internal and external audits (regulatory / customer). Ensure adherence to laboratory safety and quality system requirements . Train junior analysts on analytical techniques and documentation practices. Required Skills & Competencies: Hands-on experience in HPLC operation and method validation (Empower / Chromeleon preferred). Strong understanding of pharmaceutical formulation analysis and regulatory guidelines (ICH, WHO, USFDA, MHRA) . Excellent knowledge of UV spectrophotometry and other QC instruments. Good communication, analytical, and documentation skills. Ability to work independently and manage multiple analytical tasks. Job Type: Full-time Pay: ₹20,000.00 - ₹60,000.00 per month Work Location: In person