DPI QA Inspector II (IT)

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 Inspector II (IT)

Location: 7 Oser Avenue, Hauppauge, NY (Onsite)

Employment Type:Hourly/Full Time

Salary Range: $18.72 - $26.00

(Base/Hourly)

Benefits: In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance a" medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) a" vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.

Shift: General 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:

• Perform detailed reviews of the equipment audit trails associated with batches during production. Verify that each modification or action taken within the system (e.g., data entry, process changes, approvals) is appropriately logged, timestamped, and attributed to the correct users.
• Ensure that all changes to batch records are valid and consistent with the intended production process. Investigate any discrepancies or unauthorized actions in the audit trails and escalate as needed.
• Review user activity logs within the batch record systems to ensure compliance with 21 CFR Part 11 requirements, particularly ensuring that electronic signatures, timestamps, and system access are appropriately documented and validated.
• Ensure that all batch records and associated audit trails comply with 21 CFR Part 11 requirements for electronic records and signatures, ensuring that all system actions are secure, traceable, and compliant with regulatory standard.
• Review of the batch records (manufacturing and packaging) to ensure compliance with GMP, regulatory standards, and internal procedures. Ensure that all relevant data (e.g., production parameters, test results, material lot numbers) is captured accurately and completely.
• Oversee the validation of IT systems used in manufacturing processes, ensuring systems are properly qualified (IQ/OQ/PQ) and meet regulatory requirements.
• Identify and investigate discrepancies or anomalies within the audit trail and escalate issues where unauthorized actions, missing records, or other violations are detected.
• Provide necessary documentation and audit trail reports during internal and external audits (e.g., FDA). Ensure that batch records and audit trails are readily accessible and properly formatted for regulatory review.
• Assist in the training of staff on proper documentation practices, focusing on audit trail review.
• Ensure that all reviewed batch records and audit trail documentation are properly stored, maintained, and accessible in compliance with internal and regulatory requirements for record retention.
• Collaborate with cross-functional teams (e.g., IT, production,) to identify opportunities for improving the batch record review process, particularly in relation to audit trail management and data integrity.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOPas.
• Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
• Other duties [additional support] that management may assign from time to time.

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: Bacheloras 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.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Ciplaas respiratory business in the United States.

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

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.