• Responsible for the operations of the HPLC section, GC Section and In-process section in QC department.
• Allotment of work to the Chemist.
• Identifying training needs of the staff in the department.
• Ensuring that all Analytical Instruments are in good working condition.
• Ensuring that the raw material, in-process, Intermediates and finished products are analyzed as per set procedures.
• Review of new SOP's and STP's.
• Coordinating with the purchase department for regular supply of consumables.
• Coordination with the external testing laboratories for analysis.
• Ensuring that all documentation work is completed on time.
• Ensuring a safe environment is maintained in the laboratory.
• Review and approval of stability protocol & stability data generated time to time.
• Release of raw materials, packing materials & intermediates. Analytical release of finished product.
• Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved.
• Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact.
• Investigation the OOS and OOT occurred in the laboratory.
• Regularly supporting and providing the data as per the requirement from customer and regulatory.
• Review and approve the analytical method transfer protocols and reports.
• Regularly provide the training to the down the line people.
• Involve the customer audits to provide the answers for his quarries.
• Conducting interviews for new recruitments.
• Ensure the data integrity checks are conducted regularly to evaluate the health of the system and implement actions as required
• Responsible for continuous improvement on 21CFR compliance.
• Responsible for Laboratory Incident investigation.
• Preparation of customer related investigation reports.
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.
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