- To execute analysis of finished goods / Stability samples / Raw materials / Packing materials In-process and cleaning samples along with relevant laboratory documentation.
- Intimation & result reporting after completion of analysis & relevant documentation.
- Check all the instruments on the equipment required for the analysis are in working condition and are in calibrated state.
- Checking and ensuring proper status labels after confirming availability of all the requirements (as applicable) for analysis such as approved control procedure, analytical protocol, reference standards, chemicals, reagents, GC/HPLC Columns, glassware, water preparation equipment, water bath, sonication baths, mobile phase bottle etc.
- Ensure the online documents pertaining to day-to-day analysis are efficiently completed in timely manner. Reporting the activities daily to immediate supervisor.
- Calibration of Equipment’s / Instruments.
- Destruction of QC Samples like Retention samples, analyzed samples etc.
- To take out the quality reports, Data / Results entry in SAP system.
- To prepare and maintain the working standards & documentation.
- Ensure timely raising and closure of deviations, quality events, change controls, OOS/OOT.
- Execution of Analytical method validation, cleaning validation of Products.
- Preparation and maintenance of Analytical data sheets and Excel spread sheets.
- Adequate knowledge of all equipment/instruments & their functioning in the laboratory & assist in equipment/instrument qualification activities.
- Ensuring the quality and integrity of all GxP data and documentation generated.
- Ensuring effective execution requirements of food regulations (US)-21 CFR Part 111.
- Ensure fully Engagement and Involvement regarding awareness, clarity maintained related to data integrity.
- Ensure the 21 CFR Part 11 compliance in the Laboratory.
- Effective implementation of practices like cGMP & GLP, ISO 9001, ISO 14001, ISO 22000, ISO 18001, HACCP and SQF in QC Dept.
- To follow and maintain the standard chromatographic practices.
- Ensuring good housekeeping and accident-free working in the Laboratory.
- To perform safe Laboratory operations (as per MSDS) ensuring proper usage of PPEs, safe, secure storage of hazardous, toxic, explosive, corrosive, irritant materials.
- Ensure proper maintenance of HPLC and GC column and related logbooks in QC lab.
- To fulfill the analytical requirements of FSSAI regulation.
- To undergo assigned trainings on cGMP, HSE & departmental procedures / policies.
- To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
- To implement QEHS policy & objectives.
- To ensure participation and consultation of worker.
- To identify & communicate incidents, QEHS non conformities, investigate and take corrective actions on the same.
- To ensure work permit system during maintenance activities.
- To ensure disposal of waste.
Qualifications
M.Sc. Analytical/Organic ChemistryExperience- 3-5 years
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 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.
