Job Description

Company Description
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.

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

Skills Required