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Team Member - Quality Control

  1. Quality Control
  2. Pydibimavaram
  3. GMO

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. 

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable.  Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.


Job Description

Job summary
We are seeking an individual to test samples and release results within Turnaround Time (TAT) for commercial and stability batches, adhering to GMP (Good Manufacturing Practices). This role involves calibrating and maintaining assigned equipment within departmental and organizational guidelines, processes, and procedures. The primary objective is to ensure accuracy in results provided within timelines.

Roles & Responsibilities

  • Adhere to the Organizations safety Policies, procedures and norms, effective from time to time in QC laboratory and related areas.
  • To undergo Safety, GMP Training and to ensure adherence to Safety and GMP consistently.
  • Perform the analysis and reporting of operating supplies, finished, In-process, stability, Packing and Raw materials.
  • To perform the result recording and performing SAP transaction in quality Module.
  • To ensure general and critical area entry-exit procedures as per respective SOPs.
  • To report that the quality notification Incidents, Out of specification as per requirements.
  • Ensure timely preparation and review in Labware LIMS of the Record of Analysis , COA and Analytical reports related to QC departments. To perform the qualification of the instrument/equipment in Quality control department
  • Ensure adherence to Good Documentation Practices while entering/ recording the data in GMP documents.
  • Preparation of protocols, investigation reports as per requirements.
  • TTo coordinate with the HOD and other related departments for the smooth execution of work.
  • To ensure that all documents are updated/revised periodically to meet cGMP standards.
  • To ensure timely execution completion of calibration, preventive maintenance, Qualification /Requalification and Validation/Revalidation of equipment as per schedule.
  • To ensure all GTP, SOP, Specification and protocols training completion before starting the activities.
  • To prepare/execute to Qualification/ Validation/ Calibration/ Verification documents protocols and summary reports of testing and analysis for QC equipment.
  • Responsible for handling SAP, FIORI, DOC HUB application and other software related to QC department like Empower, LIMS as and when installed.
  • To Perform Analytical Method Validation and Analytical Method transfer for related products.
  • To perform any other task/project assigned by QC head from time to time.

Qualifications

Educational qualification: MSc Chemistry, B Pharma

Minimum work experience: 4-10 years

Skills & attributes:

Technical Skills

• Analysis of RMPM samples, IPFP Stab samples, Calibration of analytical instruments

Behavioural skills
• Prioritizes effective communication and demonstrates a performance-oriented mind-set.
• Effective verbal and written communication skills.
• Performance-oriented approach, consistently striving for high standards.
• Demonstrates flexibility in working shifts and a clear understanding of team dynamics.


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