Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Senior Executive - QA Job Description Personnel with Analytical QA background. Review analytical raw data, electronic data, and audit trails for laboratory instruments. Ensure laboratory compliance with GMP/GxP requirements and established procedures. Investigate and manage QMS events- including OOS, OOT, OOE, deviations, and incidents. Review, approve, and maintain analytical SOPs and quality documents for continual improvement. To carry out activities of Analytical QA personnel. Review of analytical raw data and documents. Review of electronic data and audit trail for instruments like HPLC, GC-MS, ICPMS, LC-MS, XRPD. Monitoring compliance in laboratory as per laid down procedures. Investigation of QMS – OOS, Deviation, Incident, OOT, OOE. Review of Analytical SOPs for compliance requirements and continual improvement Review and approval of analytical documents such as specifications, test procedures, analytical method validation / verification protocols & reports, Analytical method transfer protocols & reports, stability reports, investigation reports, trend reports etc. Review and approve the raw material, packing material, finished product analytical data. Review of Product development reports. Review of computer system validation documents. Prepare SOPs related to QA Department. Periodic review of analytical records (instrument logbooks, calibration records, standard management records etc.) Impart induction training on topics and on which training has been taken. Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.