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General Manager
4 months ago
ROLE OVERVIEW/ PURPOSE :
- The General Manager - IT is expected to adopt the latest technologies for IT infrastructure and networking systems
- which is crucial for meeting the overall objectives of the organization and compliance of Glenmark site's Quality,
- Manufacturing and Engineering systems with current GxP and GAMP5 requirements. This role encompasses the
- responsibilities of IT Quality Assurance and Electronic System compliance with expertise in Computer System Validation
- related activities at our Manufacturing plants. The incumbent will also play a key role in providing coaching and
- leadership to nurture and motivate the team to create an environment conducive to high performance.
OVER ALL JOB RESPONSIBILITIES :
- Understand the QMS requirements and collaborate with cross-functional teams within Glenmark to ensure quality standards for software development, infrastructure management, and data integrity
- Formulate and implement plans/processes w.r.t CSV and other relevant documents to meet business requirement and compliances
- Monitor the compliance part of digital systems as per the guidelines during implementation & post PQ
- To provide regular, accurate and timely reporting of progress to the Site and Corporate leadership
- To be responsible for periodic review of the IT QA audits and activities
- To adapt & authenticate new functionalities as per pharma business requirement and build proper execution plan to meet regulatory requirements
- Select latest technologies for IT-Infrastructure & Networking systems and build proper strategies to meet overall objectives of organization
- To oversee and support for managing full validation lifecycle of Software applications | systems | infrastructure, providing sound understanding of validation, qualification and testing requirements of manufacturing equipment, computer systems for the site e.g. site specific implementation of Enterprise applications like SAP ERP, Trackwise, Document Management Systems, Testing and Training Systems and Quality and Manufacturing systems like SCADA, PLCs, MES (eBMR, L2 Integration), LIMS and other highly complex automated systems
- Assess, Evaluate, Monitor and carry out periodic reviews of Computer systems for validation, user access management, data integrity, and compliance with relevant regulations - Provide coaching and leadership to nurture and motivate the team to create an environment conducive to high performance
Professional Experience:
- 15+ years of industry experience with significant exposure to GxP environment, lab equipment and instrument application
- Strong understanding and knowledge on IT Infrastructure
- Strong understanding of pharmaceutical regulations (GxP, GAMP, FDA 21CFR Part11, EU GMP Annex 11 & Annex 15, etc.) as they relate to IT systems and processes and the Computer Systems Validation requirements
- Excellent project management skills, including experience with project planning, execution, and risk management
- Proficiency in conducting audits, reviews, and assessments, with a keen attention to detail POSITION DETAILS ROLE OVERVIEW/ PURPOSE OVERALL
JOB RESPONSIBILITIES DESIRED EXPERIENCE AND KNOWLEDGE :
- Strong communication & collaboration skills to effectively interact with both technical and non-technical stakeholders
- Ability to lead a team, prioritize tasks, and adapt to a dynamic and evolving industry landscape
- Proven experience in managing CSV projects in a cross-functional and regulated environment.
- Knowledge of ERP, DMS, Trackwise, SCADA, PLC, L2 LIMS, E-BMR, MES, LIMS, Serialization - Track & Trace related requirements and other applications within a Pharmaceutical industry will be an added advantage
Education Qualification :
B.E/B.Tech or equivalent Bachelor's Degree from a well-respected educational institution is a must, a higher qualification i.e. MBA/Post Graduate degree will be additionally preferred.
Knowledge & Skills (Functional / Technical) :
- Exceptional communication & interpersonal skills
- Analytical thinking & problem solving skills
- Flexible and ability to adapt to different working environments
- Project & team management skills
- Innovative approach
Certifications :
- PMP or equivalent training or certification
- Business Intelligence training
- CSV training
- GAMP5 training
- Information security training ISO 22313 training
- ITIL training
- Knowledge of ISA standards like ISA 88 and ISA 95
- Knowledge of training & validation process
