MSAT Specialist - Process Engineer

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
 

1. 1. Assess the knowledge transfer and absorb the knowledge from the transferring sites.
   2. Understand and Establish the required documentation from the technical perview of the process for the equipment through URS for complex products.
   3. Evaluate the capabilities of the equipment along with the site layout for placing the complex equipment
   4. Perform the FMEA of the Complex equipment from an end to end (Product initiation to Commercialization)  along with involvement of the FS. FDS SDS SAT activities and FAT activities.
   5. Trouble shoot the Equipment challenges from Scaleup to Process validation stages involving Lyos HPH ILHM Filling lines Compounding vessels Isolators.
   6.  Preparation review and approval of New product introduction Change controls Technical Protocols Reports and Product impact assessments related to Process validation.
   7. Include in the identification of the Root cause analysis for any OOT / OOS of the Products introduced at sterile facilities till Process validation.
   8. Support for Regulatory filings and Compliance issues for Sterile injectable products.
   9. Support for Regulatory audits.
   10. Absorb and transfer the products from the transferring site to FTO11 and other sterile facilities with Proactive approaches and risk mitigation strategies.
   11. Monitoring and support for scale up manufacturing of process validation batches and first commercial batch for sitetosite transfer injectable product and new products from IPDO (as required).
   12. Provide support for trouble shooting root cause analysis and product impact assessments for nonconformance (incidents OOS OOT & Market complaint) investigation and process changes/ improvements.
   13. Preparation review and Approval of Operational and process SOP.
   14. Initiation review and Approval of change control and Risk assessments with respect to Validation and qualification activities
   15. Coordination with CFTs (i.e. Production QA QC) for Exhibits and Process Validation batches and BMR activity and various documentation.
   16. Preparation and review of Cleaning Validation and process related documents (Protocols Reports Master Plan and Assessments etc.)
   17. Preparation and review of CPV schedule and reports.
   18. Review of Product Quality reports (PQRs).
   19. Training of employees.
   20. Serve as the fill finish process as subject matter expert.
   21. 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 Masters (M.Tech. or M.Sc.) or a Ph.D.

Minimum work experience: 510 years (with Ph.D.) or 815 years (with Masters) 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 laboratoryscale to larger production scales and transferring technology between different manufacturing sites and other contract manufacturing organization 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 decisionmaking 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 crossfunctional teams.
Good Interpersonal skills and capacity to work collaboratively with crossfunctional teams like R&D manufacturing SCM quality assurance regulatory affairs and others.
Strong analytical and problemsolving 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. 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 !/ 

Remote Work :

No

Employment Type :

Fulltime