Dr. Reddy’s Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities..
- Important Details :
- Post of date:26/11/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job Description : Greeting from Dr.Reddys Laboratories Ltd..!!!!
Vacancy details:
- Department: QA- Associate
- Educational qualification: A B.Pharm. or Post-Graduation (Life Sciences)
- Minimum work experience: 6-8 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering.
- Job Location: Hyderabad
Job Summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves supporting in establishing the Quality Management Systems, review and monitoring the performance of Quality Management Systems.
Roles & Responsibilities
Review of procedures relating to Quality Assurance and implementing the global procedures at site with effective training.
Deviation Management System :
Establishing the deviation management master data in the application and management of changes and facilitating the implementation to site.
Review daily logged devaitions for their category and adequacy of investigations and taking appropriate actions with line QA.
Escalating the serious deviations for their immediate action towards Quality Defect Notification and identifying the oppurtunities for Quality Risk Assessment.
Dip-stick review of closed investigations for their appropraite root cause identification, adequate CAPA.
Quarterly Trend analysis of deviations for their repeatetive nature and identifying the oppurtunities for holistic CAPAs.
CAPA Management System :
Review of adequacy of Corrective Actions and Preventive Actions and periodic discussing with line functions for their adequacy.
Change Management System :
Review of change controls for their category, adequacy of supportive documents, post change effectiveness requirements.
Coordinating the change control review meeting for all signficant changes across QA Leads and QPs and review of change proposals for change notification requirements.
Tracking the change controls for regulatory notification for their implementation.
Maintenance of daily routine logs and developing the team to analyse the data in an appropraite meaningful manner.
Facilitating the training across the quality management systems including the digital systems and processes.
Quality Risk Management System :
Review of Quality Risk Assessments for their mitigiation plans and creating the risk register for site.
Communicating the high risks to the senior leadership team.
Technical Skills
• A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• Ability to develop simplified and robust quality systems.
Ability to trouble shoot the issues with simple solutions.
Knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
• Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.
• Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.
• Ability to understand and implement organizational policies and ensuring compliance.
Behavioural skills
• Demonstrates a commitment to continuous learning.
• Strong communicating and influencing skills.
• Displays analytical and logical thinking abilities.
• Is self-motivated and takes initiative.
• Adaptability to the work environment, along with being a team player.
• Ability to go beyond boundaries, showcasing a proactive and innovative approach
