Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.
We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.
Job Description
0 Responsibilities:
- To carry out the following routine checks in the laboratory on daily basis:
- Responsibility for investigation report writing and closure of deviation, OOS and OOT.
- Qualification of working standards.
- Glassware verification & labelling.
- Routine calibration and verification of all instruments.
- Logbooks verification.
- To ensure that the documentation done is online and error free.
- To ensure the correctness of the document before submitting it for the review of Group Leader/AQA reviewer.
- Column stock, inventory, indent, requirement and routine usage verification.
- Reference/Working standard and impurities verification.
- Area upkeep and maintenance.
- Calibration schedule/document/labels routine verification.
- Carrying out qualification of equipment and timely incorporation in system.
- Preparation and review of standard operating procedure and other GMP documents.
- Carry out investigation related to incident/OOS/OOT and ensuring timely closure.
- Handling of change control, CAPA related to quality control department, ensuring timely closure and effectiveness check of implemented CAPAs.
- Ensuring that all changes related to specifications/STPs/SOPs are evaluated and percolated in an effective manner to all concerned.
- Responsible for stock preparation and its inventory i.e. chemical, standards, column etc. in LIMS.
- Responsible for execution of masters and its requirements, highlighting issues and their support for way forward in LIMS.
- Maintain analyst qualification record and instrument registration in LIMS.
- Responsible for Lab Safety and follow the JSA.
- Ensure to use the proper PPE at workplace.
- Periodic review / SPOT check of specifications / STPs in use.
- Any other responsibility assigned by Group Leader.
- Review closure of audit trails.
- Verification of outside calibration and their report.
- Tracking and updation of data related to Kaizen, Near Miss, LDM.
- Compliance Response preparation and closure support.
- Timely closure of observations related to SOI and QOI.
- Ensuring timely availability of accessories and Lab consumables for routine use (PO creation and other SAP related activities).
- Ensuring timely completion of all the training assigned to self.
- Above mentioned all activities should be performed in the presence of buddy.
Qualifications
B.Sc/B.Pharma/M.Sc.
Additional Information
About the Department
Basic knowledge on investigation and closure of OOS,OOT and deviation