Senior Executive - IT (Application Support)

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a Senior Executive - IT (Application Support) for our Pune, Maharashtra location. The role focuses on providing technical support and troubleshooting for GMP applications to ensure smooth manufacturing processes.

You will collaborate with IT, Quality, and Manufacturing, validate and maintain GMP systems, and coordinate with vendors for implementation and upgrades. A Bachelor’s degree in CS/IT and 5–8 years in a GMP environment are preferred.

Qualifications

• GMP regulations and guidelines related to computerised systems.
• Excellent problem-solving and analytical skills.
• Familiarity with GMP application software and databases (ERP, LIMS, MES, QMS, DMS).
• Proactively analyzes and uses experience to solve problems.

Responsibilities

• Provide technical support and troubleshooting for GMP applications and systems.
• Collaborate with IT, Quality, and Manufacturing to resolve issues.
• Assist in validating and maintaining GMP applications for data integrity and regulatory compliance.
• Develop and implement GMP applications as required by the org and upgrade systems.
• Coordinate with vendors during implementation and troubleshooting.
• Provide training to end-users on GMP applications per guidelines.
• Maintain documentation of incident reports and change management records.
• Stay updated with GMP regulations related to computerised systems.

Skills

GMP compliance

Problem-solving

GMP apps familiarity

Cross-functional collaboration

Education

Bachelors in Computer Science or Information Technology

Tools

ERP

LIMS

MES

QMS

DMS

Job description

Senior Executive - IT (Application Support) Pune, Maharashtra, India ..+ 1 Permanent (ENZBIO)

Job Description

Role & Responsibilities - IT - Application Support

• Provide technical support and troubleshooting for GMP applications and systems to ensure smooth operation of manufacturing processes.
• Collaborate with cross-functional teams, including IT, Quality, and Manufacturing, to resolve application-related issues.
• Assist in validating and maintaining GMP applications to ensure data integrity and regulatory compliance.
• Participate in developing new and implementing GMP applications required/procured by the organisation and system upgrades.
• Coordinate with vendors in implementation and troubleshoot installed applications.
• Provide training and guidance to end-users on properly using GMP applications as per company guidelines.
• Maintain detailed documentation of application support activities, including incident reports and change management records.
• Stay up-to-date with the latest GMP regulations and guidelines related to computerised systems.
• Assist in hosting client and regulatory audits related to GMP applications and systems.
• Responsible for ensuring the smooth operation, validation, and maintenance of GMP applications and systems.
• Collaborate with various teams and suppliers, provide technical support, and ensure compliance with GMP regulations.

Technical Skill Requirement:

• Strong understanding of GMP regulations and guidelines related to computerised systems.
• Excellent problem-solving and analytical skills.
• Familiarity with GMP application software and databases (e.g., ERP, LIMS, MES, QMS, DMS) is preferred.
• Proactively Analyzes and uses experience and logical methods to make sound decisions and solve complex problems.

SoftSkill Requirement:

• Proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint)
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
• Ability to work under pressure and meet deadlines.

Experience:

Minimum 5-8 years of experience in a GMP environment, preferably in a pharmaceutical or biotech manufacturing setup.

Qualification

Bachelor's degree in a relevant field, such as Computer Science or Information Technology.