Site Lead - Digital Ops.& Gxp

7-10 years

Not Disclosed

India

10 Aug. 21, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Dr. Reddy’s Laboratories Ltd. is a premier multinational pharmaceutical company with a presence in 66 countries and a team of over 24,000 employees. Since our inception in 1984, we have evolved from a small operation with 20 employees into a global leader in pharmaceutical innovation and access. Our mission is to accelerate the availability of affordable, high-quality medicines because "Good Health Can’t Wait."

We are committed to pioneering access, affordability, and innovation through rigorous scientific research, progressive people practices, and strong corporate governance. As the industry evolves, we aim to strengthen our core capabilities and invest in future growth, targeting to reach over 1.5 billion patients worldwide by 2030. Our sustainability efforts focus on respecting people, planet, and purpose, conserving resources, creating value, and maintaining transparency and integrity.

Dr. Reddy’s is an equal opportunity employer, dedicated to fostering a diverse and inclusive workforce. We value merit and embrace diversity in our hiring practices, ensuring a work environment free from discrimination.

Job Title: Site Lead - Digital Operations and GxP

Job Summary

We are seeking a Site Lead for Digital Operations and GxP to oversee IT operations at our plant, ensuring system administration, operational efficiency, and compliance with GxP standards. This role involves supporting business continuity, evaluating and implementing new GxP IT solutions, and driving digital transformation initiatives in Quality and manufacturing areas.

Roles & Responsibilities

IT Operations Management: Ensure seamless IT operations at the plant, managing system administration, and overseeing IT activities in line with procedures and policies.
Business Continuity: Provide support to maintain 100% uptime of GxP IT functions and ensure plant compliance with GxP IT operations.
GxP Compliance: Review procedures and address QMS notifications to maintain transparency and compliance during routine operations.
Solution Evaluation and Implementation: Evaluate new GxP IT solutions, support proof-of-concept and solution development, and assist in timely solution implementations.
Business Initiatives Support: Support the implementation of new business initiatives such as MS Teams, MS SharePoint, Yammer, and other applications aligned with global goals.
Stakeholder Collaboration: Build strong relationships with business users, senior management, and cross-functional teams to enhance IT system understanding and adoption.
Continuous Improvement: Act as a key player in continuous improvement initiatives, new instrument/equipment installation and qualification, and digital transformation in Quality and manufacturing areas.

Qualifications

Educational Qualification: B.Tech. with certifications in IT, Empower, Data Historian, Cloud Computing, etc. preferred.
Experience: 7 to 10 years of relevant experience.

Skills & Attributes

Technical Skills:
- In-depth knowledge of Pharmaceutical IT Compliance, including GxP and other regulatory standards.
- Proficiency in managing and troubleshooting IT systems within a manufacturing environment.
- Expertise in IT infrastructure design and implementation for pharmaceutical facilities.
- Familiarity with networking protocols, technologies, and troubleshooting.
- Knowledge of Computer System Validation (CSV) processes and methodologies.
- Experience with MES, DCS, cloud computing, and L2 Integration beneficial.
Behavioral Skills:
- Strong problem-solving aptitude and ability to address technical issues promptly.
- Excellent people management capabilities, including experience managing teams of 12-15 members.
- Ability to ideate and implement automation processes using digital tools and AI applications.
- Understanding of Agile methodologies in a coding environment.
- Adaptability to handle diverse IT tasks and unexpected issues in plant environments.
- Attention to detail in configuring, maintaining, and troubleshooting IT systems.
- Effective time management to prioritize IT tasks based on urgency and importance.

Additional Information

About the Department: The Digital Process and Excellence (DPEx) team leads Dr. Reddy’s digital transformation efforts, focusing on process improvement and patient-centric innovation. The team drives initiatives to reimagine the organization as a platform-based entity, leveraging data as a competitive asset, and creating digital solutions to enhance patient and customer experiences.

Benefits Offered: Dr. Reddy’s provides competitive benefits, including personalized learning programs, joining and relocation support, family benefits (maternity and paternity), medical and life coverage for employees and their families.

Work Culture: At Dr. Reddy’s, our guiding principle is “Good Health Can’t Wait.” We foster a culture of empathy, dynamism, and teamwork, believing that diverse skills united by a common purpose create transformative impact. For more details, visit our career website: Dr. Reddy's Careers.

Latest Jobs

Pharma Jobs in India

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

Site Lead - Digital Ops.& Gxp

Job Description

Latest Jobs

Manager, Cmc

Regulatory Affairs Department Assistant(Contractor)

Senior Scientist, Protein Chemistry

Medical Science Liaison

​​Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences​

Associate Central Monitor, Data Surveillance, Clinical Data Sciences

Clinical Research Associate

Project Manager

Biostatistician

Database (Programming) Analyst (Associate), Clinical Data Management

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences