Sr. Executive - ITQA (Pharma) - Steriscience

Dear Candidate,

We currently have an opening for the position of Senior Executive - ITQA (Injectables) If you have experience in sterile injectables, parenteral, vaccines, or ophthalmic and are eager to make an impact, we want to hear from you.

Company: Steriscience Specialties Pvt Ltd

Website: www.steri-science.com
Work Location: Bilekhalli (Opposite to IIM), Bannerghatta Road, Bangalore

Qualification: B. Pharm/M. Pharm

Experience: 5- 10 years (experience should be in sterile Injectables/ Parenteral/ Vaccine/ Opthalmic)

Background of job: 5 years in a Pharma IT role & 3-4 years of experience in CSV

Department: ITQA

Designation: Senior Executive

TECHNICAL COMPETENCIES

Proven experience in handling Life Cycle Management of GxP applications, Quality Management Systems, Quality Risk Assessments, Data Integrity, and Computer System Validation (CSV)
Expertise in qualification and validation processes

ROLE PURPOSE

The role focuses on overseeing and managing Computer System Validation (CSV) to ensure compliance with industry standards and regulatory guidelines. It involves QA support for IT systems and projects, ensuring systems are validated and compliant throughout their lifecycle. Additionally, the role provides guidance on quality and compliance to relevant employees.

KEY DUTIES AND RESPONSBILITIES

• Collaborate with cross-functional teams to identify IT needs and develop compliant solutions.
• Provide technical support and troubleshoot Pharma IT system issues.
• Stay updated on industry trends and advancements in Pharma IT.
• Proven experience in IT roles with a focus on Pharma IT systems and regulations.
• Ensure compliance with regulatory standards such as 21 CFR Part 11, GxP, and other relevant guidelines.
• Implement and manage pharmaceutical IT systems (LIMS, ERP, regulatory compliance software).
• Conduct GxP evaluations for computerized systems.
• Collaborate with Quality, IT, and vendors to plan and execute CSV (Computerized System Validation) activities.
• Review CSV lifecycle documentation and oversee test execution and result compilation.
• Review SOPs related to GxP computerized systems and system administration.
• Lead the CSV program to ensure compliance with regulatory standards.
• Act as a QA CSV SME for audits and regulatory matters.
• Provide guidance throughout the GxP computerized system change control process.
• Ensure data handling standards for GxP computerized systems are compliant.
• Perform quality oversight and approve periodic user access reviews.
• Ensure accurate completion and filing of CSV documentation.
• Maintain and present relevant metrics and key performance indicators.
• Review vendor qualification/validation documentation.
• Review and approve deviations and CAPAs related to computerized systems.
• Identify compliance gaps and prioritize business process improvements.
• Review and update procedural documents for process compliance.
• Collaborate with senior management to optimize CSV processes and training.
• Mentor and coach team members.
• Work closely with the CVG team to ensure validation requirements for systems like PLC, HMI, SCADA, DCS, etc., are met.
  

Interested candidates can share their resumes to Pooja.Thakkar@arcolab.com with subject line Resume ITQA - Injectables