Team Member Cleaning Validation- Manufacturing Science & Technology (MSAT OSD)

Job Summary
We are looking for a detail-oriented individual to lead the implementation of cleaning validation procedures and protocols ensuring compliance with regulatory standards and Good Manufacturing Practices (GMP). This role involves preparing and reviewing SOPs validation plans and reports contributing significantly to the quality management system and regulatory compliance efforts within the organization.

Roles & Responsibilities
You will be responsible for preparation review and approval of Cleaning Master Validation Plan Cleaning Validation and Verification Protocols and Reports Acceptance Criteria documents Cleaning Validation matrix and Periodic Monitoring Schedule. 
You will be responsible for implementing and complying with the cleaning validation SOP (Standard Operating Procedure) and the Cleaning Validation master plan.
You will assist in preparation and review of SOP Operating Instruction Standard Cleaning Procedure.
Your responsibilities include compiling cleaning validation reports by summarizing reported data updating periodic monitoring schedule as required and providing support in identifying hard-to-clean locations and deriving surface area for contact parts.
You will track and manage execution of cleaning validation activity.
You will also review and approve QMS (Quality Management System) documents such as incidence reports change controls etc.
You will be accountable for ensuring that validation activities are carried out according to the protocol and in compliance with cGMP (Current Good Manufacturing Practices) cGxP (Current Generally Accepted Practices) and regulatory requirements.
Your role extends to assisting preparation and review of risk assessments URS (User Requirement Specification) and Design Qualification documents related to cleaning validation activities.
You will be expected to participate in internal and external audits providing explanations of cleaning validation related documents to auditors and inspection teams.
You will be responsible for QMS management including initiation approval and closure of change controls incidents audit compliance and impact assessment.
For all cleaning validation related activities your role involves providing support to internal and external stakeholders providing training to personnel and participating in digitalization and simplification of activities.

Qualifications :

Qualifications

Educational qualification: Bachler of pharmacy / masters in science / pharmacy

Minimum work experience: 3-7 years of experience in Cleaning Validation

Skills & attributes:

Technical Skills

• Experience in the execution of cleaning validation activities for products in Solid dosage forms.
• Experience in Swab sampling activities.
• Ability to prepare technical protocols and reports.
• Experience in risk assessment approaches. 
• Knowledge of PDA Tech report 29 ISPE APIC and other relevant guidelines.
• Familiarity and proficiency in using CLEEN software.
• Experience in Analytical Research and knowledge on interpretation of the data.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Performance oriented and good at building leveraging relationship.
• Ability to work collaboratively with own team and cross-functional teams.
• Committed to Learning & Coaching the team. 

Additional Information :

About the Department
IPDO/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