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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
Senior Executive - Quality Control
Job Description
Executive- Quality Control (RM/FG/Stability)
Experience: Minimum 3-5 years of experience in analysis of RM/FG/Stability/PM samples using various QC instruments (HPLC/GC/UV/IR/Autotitrator/Polarimeter etc.)
Qualification: M.Sc. (Analytical/Organic Chemistry).
To execute analysis of finished goods / Stability samples / Raw materials / Packing materials In-process and cleaning samples along with relevant laboratory 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 respective records & QC samples like retention samples of raw materials, analyzed samples.
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.
Ensuring good house-keeping 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.
Skills Required
analytical method validation , autotitrator , polarimeter , Excel, Hplc, Ir, Gc, Uv, Cleaning Validation
