28 Sep
|
Zydus Lifesciences
|
Baddi
28 Sep
Zydus Lifesciences
Baddi
- To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI.
- 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 / SAP / 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 prepare and 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 review Pharmacopoeial reference standards against their catalogue & its procurement.
- 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 public testing 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.
- To keep himself / herself 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 laboratory incidence/ OOS/ OOT/ OOC on its immediate occurrence and for day to day activities.
- To investigate laboratory incidence/ OOS/ OOT/ OOC (if any) under consultation with the department head/section head.
- To manage all standards for issuance and its usage.
- To perform the calibration of instruments as per the planner and / or as and when required.
- To manage all calibrators used for calibration and their documents.
- To perform the qualification of instruments as per the requirements.
- To co-ordinate with in-house service engineers and / or external service engineers as and when required.
- To raise change controls applicable to quality control laboratory and testing.
- To prepare the standard operating procedure for quality control department.
📌 Quality Control Officer (Baddi)
🏢 Zydus Lifesciences
📍 Baddi