NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates. Job Title: QA Associate (IT)
Location: Hauppauge, NY (Onsite)
Employment Type: Full Time - Salaried/Exempt
Salary Range: $76,000-$103,000
Work Hours/Shift: 8:30AM - 5:00PM
Job Overview: The QA Inspector (IT) in a pharmaceutical manufacturing environment focused on Dry Powder Inhalers (DPI), you will ensure the integrity, compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for validating and verifying the IT systems supporting manufacturing processes, with a particular focus on audit trail review, data integrity, and overall GxP compliance.
Responsibilities:- Develop, review, and approve CSV documentation including Validation Plans, Risk Assessments, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Test Plans, IQ/OQ/PQ protocols, and Validation Summary Reports.
- Ensure validation activities comply with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5).
- Participate in system implementation projects to ensure validation requirements are met from planning through deployment.
- Perform QA oversight for IT systems used in GMP environments, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems.
- Initiate, Review and approve change controls, deviations, CAPAs, and audit trail reviews related to computerized systems.
- Ensure systems are maintained in a validated state throughout their lifecycle.
- Author and maintain Standard Operating Procedures (SOPs) related to CSV, data integrity, and IT compliance.
- Ensure documentation practices align with ALCOA+ principles and data integrity standards.
- Support internal and external audits by providing documentation and subject matter expertise on validated systems.
- Address audit findings and implement corrective actions related to IT systems and CSV.
- Work closely with IT, Manufacturing, Quality Control, and Regulatory Affairs to ensure systems meet business and compliance needs.
- Provide training and guidance to stakeholders on CSV and data integrity requirements.
- Conduct risk assessments for computerized systems to determine validation scope and testing rigor.
- Identify and mitigate compliance risks associated with IT systems.
- Stay updated on regulatory trends and industry best practices in CSV and data integrity.
- Recommend improvements to validation processes and system lifecycle management.
Any other activity assigned by Section Head, Unit Quality Assurance and Site Quality Head.
Skills:- Excellent attention to detail and ability to review complex batch records and audit trails.
- Strong understanding of 21 CFR Part 11 regulations, GMP, and other regulatory standards for pharmaceutical manufacturing.
- Experience with electronic batch record (EBR, SCADA) systems and other pharmaceutical IT systems.
- Understanding of audit trail principles, data integrity, and electronic signatures in regulated environments.
- Strong communication skills for preparing reports, providing feedback, and interacting with cross-functional teams and auditors.
- Analytical and problem-solving skills to identify potential issues in batch records and audit trails.
Educational Qualification: Bachelor's degree in Life Sciences, Information Technology, Pharmaceutical Sciences, or a related field.
Work Experience: - Minimum of 2-4 years of experience in Quality Assurance or IT Quality Assurance in a regulated pharmaceutical environment.
About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
