Msat Specialist - Process Engineer

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 and to build the future.
'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.
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.
Job Description Job Summary
We are seeking a skilled professional to serve as a specialist in upstream/downstream operations, specializing in processes and Process Engineering aspects in Sterile injectables.
The role involves authoring validation protocols, conducting risk assessments, utilizing tools for process verification, and actively participating in technology transfers to ensure compliant, efficient, and continuously improved manufacturing processes.
Roles & Responsibilities Assess the knowledge transfer and absorb the knowledge from the transferring sites.Understand and establish the required documentation from the technical viewpoint of the process for the equipment through URS for complex products.Evaluate the capabilities of the equipment along with the site layout for placing the complex equipment.Perform the FMEA of the complex equipment from end to end (Product initiation to Commercialization) along with involvement of the FS, FDS, SDS, SAT, and FAT activities.Troubleshoot the equipment challenges from Scale-up to Process validation stages involving Lyos, HPH, ILHM, Filling lines, Compounding vessels, Isolators.Preparation, review, and approval of New product introduction Change controls, Technical Protocols, Reports, and Product impact assessments related to Process validation.Include in the identification of the Root cause analysis for any OOT/OOS of the Products introduced at sterile facilities till Process validation.Support for Regulatory filings and Compliance issues for Sterile injectable products.Support for Regulatory audits.Absorb and transfer the products from the transferring site to FTO-11 and other sterile facilities with proactive approaches and risk mitigation strategies.Monitoring and support for scale up, manufacturing of process validation batches and first commercial batch for site-to-site transfer injectable product and new products from IPDO (as required).Provide support for troubleshooting, root cause analysis, and product impact assessments for nonconformance (incidents, OOS, OOT & Market complaint) investigation and process changes/improvements.Preparation, review and approval of Operational and process SOP.Initiation, review and approval of change control and Risk assessments with respect to Validation and qualification activities.Coordination with CFTs (i.e., Production, QA, QC) for Exhibits and Process Validation batches and BMR activity and various documentation.Preparation and review of Cleaning Validation and process-related documents (Protocols, Reports, Master Plan and Assessments etc.
).Preparation and review of CPV schedule and reports.Review of Product Quality reports (PQR's).Training of employees.Serve as the fill finish process as subject matter expert.To perform any other task/project assigned by reporting authority.Qualifications Educational qualification: Master in Pharmacy (M.Pharm) or Master in Sciences (M.Sc) or Master's (M.Tech.
or M.Sc.)
or a Ph.D.
Minimum work experience: 5-10 years (with Ph.D.) or 8-15 years (with Master's) of experience in a pharmaceutical industry specifically in Sterile injectables.
Skills & attributes: Technical Skills
• Thorough knowledge of sterile injectable processes, and current Good Manufacturing Practices (cGMP).
• Proficiency in scaling up manufacturing processes from laboratory-scale to larger production scales and transferring technology between different manufacturing sites and other contract manufacturing organizations to FTO facilities including the cleaning validation aspects and strategy of product and equipment.
• Experience and understanding of Continued Process Verification.
• Familiarity and proficiency in using statistical software, particularly JMP, for data analysis, interpretation, and decision-making in the context of process optimization and control.
• Expertise in authoring documents related to cGMP and developmental processes, including process validation protocols and reports.
• Ability to identify, analyse, and resolve issues or challenges that may arise during the manufacturing process, ensuring continuous improvement.
• Skills in conducting risk assessments and comprehensive understanding and application of Quality Management Systems.
• Expertise in designing, optimizing, and implementing upstream and downstream processes in a manufacturing environment.
Behavioural skills
• Ability to convey complex upstream and downstream processes and technical information clearly to diverse audiences, including team members, management, and cross-functional teams.
• Good interpersonal skills and capacity to work collaboratively with cross-functional teams, like R&D, manufacturing, SCM, quality assurance, regulatory affairs, and others.
• Strong analytical and problem-solving skills to address challenges.
• Demonstrates integrity by consistently following protocols, exhibiting trustworthiness and reliability.
• Takes responsibility and maintains a disciplined and agile approach to execution.
Additional Information 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.

#J-18808-Ljbffr