Team Member - Quality Control Job Greenlawn New York USA,Healthcare

Location: Greenlawn

Overview

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.

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

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