Quality Control

Department - Quality Control

Experience - 2 to 5 years

Qualification - M.Sc chemistry (Full time)

Section - HPLC / GC / Wet lab

• To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI.
• To perform Analysis (Chemical)of raw material/packaging material/in-process samples /intermediate /bulk & finished products/ process validation samples/ stability samples/ cleaning validation/method transfer sample, PD lab sample etc.
• To ensure that all tests carried out in the laboratory are documented contemporaneously in an appropriate authorized and controlled worksheet/ bound book.
• To make entries in the sample inward register / LIMS as required for assigning analytical reference number and to store at recommended storage condition until completion of the analysis.
• To operate and maintain laboratory equipment/instrument as per analyst qualification program.
• To ensure that entries in log books are made where ever instruments are used in the analysis.
• To perform all associated activities (bench reagents, indicators, volumetric solution preparation, factor determination etc.) required for sample testing by following the approved procedures.
• To perform analysis (Chemical) to qualify working standards against reference standard /certified standard/ primary standards.
• To ensure all primary standards/working standards/certified standards/reference standards are stored as per the storage conditions specified and documented.
• To check the availability of analytical resources like chemicals/reagents / standards etc. before start of the analysis.
• To take online print and perform data punching in the LIMS. To monitor temperature of laboratory daily.
• To send those samples to outside laboratory for analysis for tests not able to be carried out in laboratory.
• To maintain and ensure controlled laboratory practice in the quality control department.
• To document the raw data as per current GDP. To follow the SOPs of Quality control department and related area.
• To follow Specification, STP, GTP and protocol during analysis.
• To use applicable PPEs (personal protective equipment) while performing testing in the laboratory / during handling hazardous solvents/chemicals.
• To keep himself updated with current regulatory requirements and train the subordinates and colleagues for day to day activities as well as regulatory.
• To keep the things and his work area clean and tidy and get involved for the routine trouble shooting (if any).
• To ensure up-keeping of the instrument/equipment. To ensure laboratory inventory management.
• To inform section head any incident/ OOS/ OOT/ OOC on its immediate occurrence and for day to day activities.
• To investigate incident/ OOS/ OOT/ OOC (if any) under consultation with the department head/section head.
• To perform the analysis of stability samples as per the analyst qualification, requirements and respective procedure.
• To perform the calibration of instrument as per the planner and / or as and when required.
• To manage all standards for issuance and its usage.
• To co-ordinate with in-house service engineers and / or external service engineers as and when required.
• To ensure the destruction of remnant samples after analysis as per applicable procedure.
• To perform analysis at CHL inter locations whenever required. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.
• To escalate any issues related to discipline, availability of manpower, hygiene, contamination, cross contamination, Incidents or deviations, malfunctioning of equipments, any unusual observations, any safety risk or quality risk to next level or in absence further up. To perform any other activities as assigned by HOD after completion of the necessary trainings as applicable.