10 Aug
|
Sun Pharmaceutical Industries
|
Baska
10 Aug
Sun Pharmaceutical Industries
Baska
Job Summary/ Areas of Responsibility
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Computer System Qualification & Validation (CSV)
Ensure hardware qualification of computerized systems is completed as per approved protocols.
Prepare, review, and execute qualification and validation documents for computerized systems and laboratory instruments.
Perform and review software validation for recent instruments in line with 21 CFR Part 11 requirements.
Implement system and software validation for newly installed instruments/software.
2. Regulatory Compliance – 21 CFR Part 11
Maintain and secure 21 CFR Part 11 compliance of laboratory instruments and equipment.
Ensure compliance related to ERES, audit trails, software categorization, user and role management, and data security.
Act as administrative rights holder for instrument and equipment software installed at SPML Baska.
3. System Administration & IT Support
Preparation, review, and approval of System Administrator procedures for QC instrument software.
Perform IT‑related activities as defined in instrument/equipment SOPs.
Execute DTC‑related activities for the IT department.
Monitor EDMS form due dates and system documentation lifecycle.
4. SOPs, Documentation & QMS
Review, prepare, and maintain SOPs related to:
Backup of electronic data
System control policies
IT infrastructure and system security
Preparation, review, and approval of IT‑related protocols, policies, and documentation.
Preparation, review, and approval of QMS docume
📌 Executive IT (Baska)
🏢 Sun Pharmaceutical Industries
📍 Baska