Manager/ Senior Manager

1 day ago

Mumbai Metropolitan Region, India SUN PHARMA Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Title
Senior Manager-2/Manager-1

Business Unit
CQ IT

Job Grade
G9B/G10

Location :
Vadodara

Key Responsibilities
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."

Job Description –

  • Ensure compliance of all GxP computerized systems in alignment with Sun Pharma's Computerized Systems Quality Management System (CS QMS) and applicable regulatory requirements.
  • Conduct assessments of GxP systems referencing 21 CFR Part 11, EU Annex 11, and other relevant standards, focusing on data integrity, security, and control mechanisms.
  • Review and evaluate computerized systems used in laboratory and manufacturing environments.
  • Define and manage user access privileges across Manufacturing and Quality Control (QC) systems to ensure appropriate segregation of duties and data protection.
  • Oversee IT compliance activities for Manufacturing and Lab systems, including:
  • Verification of security policies
  • Monitoring and investigation of backup and restoration processes
  • Review OEM and CSV qualification documentation for manufacturing systems to ensure alignment with compliance standards.
  • Conduct gap assessments of GxP computerized systems across manufacturing and lab areas.
  • Assist sites in addressing internal and external audit observations related to computerized systems.
  • Apply knowledge of Computer Software Assurance (CSA) principles to enhance validation and compliance strategies.
  • Perform proactive cross-site assessments to identify and mitigate recurring audit findings.
  • Prioritize and support remediation programs based on risk assessment.
  • Provide guidance for upgrading legacy systems to meet current regulatory expectations.
  • Facilitate implementation of global Quality-IT initiatives across sites.
  • Ensure documentation related to computerized systems meets quality standards throughout the system lifecycle.
  • Mentor and train personnel on compliance and validation practices for GxP IT systems.
  • Develop and harmonize global procedures for lab and manufacturing systems to ensure consistency and standardization.

Travel Estimate
High (Frequent travel required)

Job Requirements
Educational Qualification
B. Pharm/M.Sc

Experience
12 Years-18 Years

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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