QMS Specialist (EU Quality)
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Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
- Ensuring that all activities are performed in accordance with regulatory and legal requirements and in compliance with current GMP GDP company SOPs and Health & Safety policies/SOPs.
- Participating in the creation implementation monitoring review and continuous improvement of cGMP Quality Management Systems (QMS) and related procedures as assigned or required by the Head of Quality
- Reviewing and making decisions regarding the disposition of change controls deviations complaints product recalls CAPAs and evaluating CAPA effectiveness.
- Reviewing product return lists and forwarding them to the Responsible Person (RP) for decisionmaking.
- Preparation for and coordination of audits conducted by regulatory authorities.
- Participating in Quality Risk Management activities including risk assessment mitigation planning and periodic review.
- Performing trending and analysis of QMS elements such as change controls deviations complaints product recalls and CAPAs.
- Reviewing and updating core/apex documents including the Site Master File to ensure current and compliant information.
- Conducting external audits in collaboration with the Lead Auditor liaising with clients and auditors and ensuring that all audits are planned executed and completed within the defined timelines.
Qualifications :
Bachelor or Masters (preferred) in Pharma with QMS / QA experience.
Proficiency in English is must as candidate will be working with EUG Quality Team.
Additional Information :
About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys 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.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Dr. Reddys 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 Cant Wa ... View more
