Key Roles/Responsibilities: To ensure cGMP in Quality Control laboratory. Review of QC / QA documents. Review and approve OOS, OOT, Incident, deviation and QC laboratory data and stability summary sheet. To prepare QMS (OOS, OOT, Lab Incident and Quality Event) Trends as per said procedure. To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia changes like IP,BP,USP,Ph.Eur,JP etc. To review of QC laboratory records on periodic basis. To impart training to QC Laboratory personnel on SOPs, on-job training, regulatory requirements and guidelines. To ensure compliance of Qualification and calibration planner for QC instruments. To review QC Laboratory records (Issuance and archival of the documents like Laboratory note Book, Chromatograms, COA etc.). To provide Quest data on monthly basis to concern person. To perform self-audit of QC laboratory on periodic basis. To take the responsibilities of the activity in absence of immediate superior. To review audit trail for QC Instruments. To assign/disable password for QC Biometric system. Ensure compliance to KRA’s and other such assignments. Analytical and Electronic data review of respective batches at the time of release. Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site. Issuance and management of HPLC and GC column. Verification of admin audit trail along with IT person. To perform level-3 signoff for QC instruments wherever applicable. In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
