QC Analyst

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 QC Analyst Job Description To execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics Key Roles/Responsibilities: · Perform batch disposition and stability activities in a proactive and timely manner which includes Quality Control testing and reporting of raw materials, in process, bulk drug substance, final products and · stability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good · Documentation Practices for Electronic Data. · Perform stability study programme activities, storage of in process, and final products samples and retention sample management · System owners of QC equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Quality Control department. · Ownership and accountability of deviations, investigations and laboratory investigations and timely completion of these documents · Preparation and update of SOPs, instructions and protocols and other Quality Control documentation · Checking and reviewing of data in compliance with Data Integrity requirements · Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives. · Calibration of equipment and instruments used to perform QC testing and informing relevant personnel in a timely manner of any failure of calibration · Maintain Quality Control information systems · Maintain a technical ability, knowledge and understanding of relevant regulatory requirements for GMP, safety and environmental policies required in order to perform role as QC Analyst · Assist in investigation of quality incidents and other problem solving forums and complete QMS documentation in a timely manner. · Attend internal and external scientific and technical meetings and conferences where appropriate · Carry out general maintenance and house keeping of equipment and laboratories · Available to provide cover for other departments within the organisation as required · Available to undertake any other duties as requested by the QC Manager in accordance with Company requirements Competencies: · Attention to detail · reliability · effective communication understanding of scientific and technical processes 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.