Team Member - Production
Dr. Reddy's Laboratories
- Visakhapatnam, Andhra Pradesh
- Permanent
- Full-time
We are looking for a candidate to oversee manufacturing operations, managing equipment, process validation, handling change controls, deviations, incidents, and ensuring compliance with regulatory audits. Responsibilities include creating SOPs (Standard Operating Procedure), providing training, and applying expertise.Roles & Responsibilities
- Follow and adhere to the SOP's and other laid down the procedure in the production
- Follow and adhere to the company safety norms, company policies and procedures in the departments.
- To ensure effective implementation of Company policies and Procedures in the departments.
- Initiation of Quality notification, breakdown notification and change control in SAP.
- Preparation and review of investigation report.
- Initiation and closure of CAPA as per procedure.
- Review and Approval of SOP, URS, Protocols, reports in DOCHUB.
- Review and Approval of workflow, recipe and eBMR in MES.
- Conduct group discussion related to incident investigation to find the cause of discrepancy.
- Participate, Preparation and review of Risk assessments.
- To review and approve Validation, Qualification Documents and related reports as per requirement.
- Preparation and Review of alarm trending of equipment.
- To perform and review GxP assessment, system level impact assessment and CSV qualification.
- To ensure that the qualification, Validation, Calibration of equipment and process validation are done as per schedule and requirement.
- To review and approve Validation, Qualification Documents and related reports as per requirement.
- Scheduled and execution of Manufacturing plan.
- Planning of routine activities, manpower planning and work allocation for manufacturing.
- Responsible for activities like Dispensing and Manufacturing ( Blending, Granulation, Compression, Coating, Capsulation, Imprinting and Inspection ) as per Production plan.
- Coordination with operators for smooth running of manufacturing activities.
- To coordinate with the research and development and development and manufacturing sciences and technology team for planning and execution of the Exhibit Batches in the manufacturing Department.
- To ensure smooth coordination with other related departments- Warehouse, HR, Admin, Engineering services, QA, QC, MSAT, IPDO and SHE.
- To ensure timely completion of calibration & Preventive maintenance activities of manufacturing equipment's.
- To coordinate with engineering department to reduce manufacturing breakdown time and ensure proper rectification of the problems occurred.
- To attend inventory & production planning meeting and accordingly ensure proper material and manufacturing.
- To perform Spot checks and GEMBA walk as per schedule.
- To ensure that the required initial and periodic training of department personnel in completed as per schedule and give the training to below team members as when required.
- Review of area environment monitoring trends.
- To ensure that material indents are done as per the requirement and to review and approve the purchase indents for department.
- To prepare and circulate the Daily Production Report to HOD.
- To review the market complaints in coordination with QA Department and taking the required corrective and Preventive action.
- Review of Executed eBMR & workflows and ensure the submission to IPQA department on time.
- Review the Audit trail reports of equipment.
- To Perform any task/project assigned by HOD.
- To perform the duties of Designee for Head of the department whenever HOD is absent / busy in other activities.
- To perform Batch release system on time as per Market requirements.
- As part of all team area readiness, maintain to meet the current regulatory compliance & norms
- Expertise in line operations, especially in manufacturing activities like CIP and batch manufacturing.
- Proficiency in understanding equipment such Granulation, Compression, Coating, Capsule Filling, Imprinting and Inspection etc.
- Understanding of Process Validation for Potent Oral Solid Product and cleaning procedures.
- Knowledge for evaluation of change control, deviation, incident, out of specification, out of trend, and risk management.
- Experience in preparing production process SOPs and batch records.
- Understanding and application of Aseptic processes, Lean, OEE, and similar KPIs.
- Hands-on experience in regulatory audits, particularly with agencies like the US FDA.
- Capacity to provide training on good manufacturing practices and other relevant areas.
- Demonstrates a proactive approach to identifying and solving challenges in manufacturing processes.
- Exhibits a keen attention to detail in handling complex manufacturing activities, ensuring precision and accuracy.
- Collaborates seamlessly with cross-functional teams, promoting a cooperative and inclusive work environment.
- Efficiently manages time to meet production schedules and deadlines without compromising quality.
- Displays a willingness to stay updated on industry trends, regulations, and emerging technologies, contributing to ongoing professional development.
- Knowledge of working in regulatory environment like USFDA, MHRA, TGA.
- Should have good understanding of cGM, cGDP, and good laboratories practice.
- Must have hands-on experience in sophisticated manufacturing machine and equipment.
- Effective communication and training skills for user departments and service providers.
Global Manufacturing Organisation (GMO)
At 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.
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 1,150+ 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. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy's 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. Reddy's why they come to work every day and they'll say, because Good Health Can't 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 we're 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 https://careers.drreddys.com/#!/