Senior Manager-QC

Job Description Job Description - Responsible to complete the work assigned and ensure the training on the activity which are assigned by supervisor/ HOD-QC prior execution. - Review of packing materials, raw materials, stability samples, in process and finished products data. - Review Qualification, Validation, Calibration data, Procedure, Audit Trail on timely manner. - To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness. - To receive and Inward the analysis sample includes packing materials, raw - materials, In-process, Intermediate, API, Finished product, Stability samples and - make entry in to the respective AR number logs. - To allocate work of chemical and Instrumentation area and Ensure timely completion of work. Ensure allocated work is inline with Analyst Qualification reports. - Review QC Logs, Incidences, Reports and ensure document archival after released of samples. - Ensure Control sample inspection and Leftover sample disposal after analysis. - Ensure Instrument calibration and AMC done as per the schedule. - Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement. - Conduct Training on SOPs, Trending and any other relevant procedure. - Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports. - Involved in Investigation and Ensure effectiveness of CAPAs. - Performa SAP activity and Ensure closer of QMS before release of Batches in SAP. - Actively involve during LIMS deployment, act as LIMS admin, aware about CSV - LIMS data management, Mater data creator and static maintainer for LIMS. - Shall perform assessment,and supporting to investigations, deviations and implementing CAPA effectively. Qualifications - Graduate/Postgraduate Science degree, Pharma preferably in a relevant scientific/technical field/ Pharmaceutical Sciences and 18 or more years of relevant experience in a highly regulated environment. - Should have a minimum 4 years experience of Heading department. About Us 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. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.