Cipla USA
Overview
Join to apply for the
DPI QA Inspector II (IT)
role at
Cipla USA . Job Title:
QA Inspector II (IT) Location:
7 Oser Avenue, Hauppauge, NY (Onsite) Employment Type:
Hourly/Full Time Salary Range:
$18.72 - $26.00 Shift:
General Shift - 8:30am - 5:00pm Notice:
This posting is for local applicants in Cipla USA. It is not for global assignments or employees outside Cipla\u2019s U.S. subsidiaries or affiliates.
Job Overview
The QA Inspector (IT) in a pharmaceutical manufacturing environment focused on Dry Powder Inhalers (DPI) will ensure the integrity, compliance, and performance of IT systems, contributing to product quality and regulatory adherence. You will validate and verify IT systems supporting manufacturing processes, with emphasis on audit trail review, data integrity, and overall GxP compliance.
Responsibilities Perform detailed reviews of equipment audit trails associated with batches during production. Verify that modifications or actions are logged, timestamped, and attributed to the correct users.
Ensure batch records changes are valid and consistent with the production process. Investigate discrepancies or unauthorized actions in audit trails and escalate as needed.
Review user activity logs within batch record systems to ensure compliance with 21 CFR Part 11, including electronic signatures, timestamps, and system access documentation and validation.
Ensure batch records and audit trails comply with 21 CFR Part 11 for electronic records and signatures; ensure system actions are secure, traceable, and compliant.
Review batch records (manufacturing and packaging) for GMP/regulatory compliance; ensure relevant data is captured accurately (production parameters, test results, lot numbers).
Oversee IT system validation in manufacturing (IQ/OQ/PQ) to meet regulatory requirements.
Identify and investigate discrepancies in audit trails; escalate issues such as unauthorized actions or missing records.
Provide documentation and audit trail reports during internal and external audits (e.g., FDA); ensure accessibility and proper formatting for regulatory review.
Assist in staff training on proper documentation practices, focusing on audit trail review.
Ensure proper storage and accessibility of reviewed batch records and audit trail documentation in line with record-retention requirements.
Collaborate with cross-functional teams to improve batch record review, audit trail management, and data integrity.
Complete assigned training and follow company policies, safety requirements, cGMP, and SOPs.
Report and escalate daily shop floor activities and batch manufacturing/packing discrepancies to the QA Manager.
Perform other duties as assigned by management.
Skills Excellent attention to detail; able to review complex batch records and audit trails.
Strong understanding of 21 CFR Part 11, 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 reporting, feedback, and cross-functional collaboration with auditors.
Analytical and problem-solving abilities to identify issues in batch records and audit trails.
Educational & Experience
Educational Qualification:
Bachelor\u2019s degree in Life Sciences, Information Technology, Pharmaceutical Sciences, or a related field. Work Experience:
Minimum 2-4 years of experience in Quality Assurance or IT Quality Assurance in a regulated pharmaceutical environment.
About the Company
InvaGen Pharmaceuticals, Inc. is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines. The company focuses on cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. InvaGen is based in Central Islip and Hauppauge, NY.
Equal Opportunity
Equal Opportunity Employer. Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected status. Cipla provides reasonable accommodations to applicants during the hiring process upon request.
Salary/pay range statements are estimates and depend on experience, skills, education, and budget. Benefits may include bonus eligibility where applicable.
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Join to apply for the
DPI QA Inspector II (IT)
role at
Cipla USA . Job Title:
QA Inspector II (IT) Location:
7 Oser Avenue, Hauppauge, NY (Onsite) Employment Type:
Hourly/Full Time Salary Range:
$18.72 - $26.00 Shift:
General Shift - 8:30am - 5:00pm Notice:
This posting is for local applicants in Cipla USA. It is not for global assignments or employees outside Cipla\u2019s U.S. subsidiaries or affiliates.
Job Overview
The QA Inspector (IT) in a pharmaceutical manufacturing environment focused on Dry Powder Inhalers (DPI) will ensure the integrity, compliance, and performance of IT systems, contributing to product quality and regulatory adherence. You will validate and verify IT systems supporting manufacturing processes, with emphasis on audit trail review, data integrity, and overall GxP compliance.
Responsibilities Perform detailed reviews of equipment audit trails associated with batches during production. Verify that modifications or actions are logged, timestamped, and attributed to the correct users.
Ensure batch records changes are valid and consistent with the production process. Investigate discrepancies or unauthorized actions in audit trails and escalate as needed.
Review user activity logs within batch record systems to ensure compliance with 21 CFR Part 11, including electronic signatures, timestamps, and system access documentation and validation.
Ensure batch records and audit trails comply with 21 CFR Part 11 for electronic records and signatures; ensure system actions are secure, traceable, and compliant.
Review batch records (manufacturing and packaging) for GMP/regulatory compliance; ensure relevant data is captured accurately (production parameters, test results, lot numbers).
Oversee IT system validation in manufacturing (IQ/OQ/PQ) to meet regulatory requirements.
Identify and investigate discrepancies in audit trails; escalate issues such as unauthorized actions or missing records.
Provide documentation and audit trail reports during internal and external audits (e.g., FDA); ensure accessibility and proper formatting for regulatory review.
Assist in staff training on proper documentation practices, focusing on audit trail review.
Ensure proper storage and accessibility of reviewed batch records and audit trail documentation in line with record-retention requirements.
Collaborate with cross-functional teams to improve batch record review, audit trail management, and data integrity.
Complete assigned training and follow company policies, safety requirements, cGMP, and SOPs.
Report and escalate daily shop floor activities and batch manufacturing/packing discrepancies to the QA Manager.
Perform other duties as assigned by management.
Skills Excellent attention to detail; able to review complex batch records and audit trails.
Strong understanding of 21 CFR Part 11, 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 reporting, feedback, and cross-functional collaboration with auditors.
Analytical and problem-solving abilities to identify issues in batch records and audit trails.
Educational & Experience
Educational Qualification:
Bachelor\u2019s degree in Life Sciences, Information Technology, Pharmaceutical Sciences, or a related field. Work Experience:
Minimum 2-4 years of experience in Quality Assurance or IT Quality Assurance in a regulated pharmaceutical environment.
About the Company
InvaGen Pharmaceuticals, Inc. is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines. The company focuses on cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. InvaGen is based in Central Islip and Hauppauge, NY.
Equal Opportunity
Equal Opportunity Employer. Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected status. Cipla provides reasonable accommodations to applicants during the hiring process upon request.
Salary/pay range statements are estimates and depend on experience, skills, education, and budget. Benefits may include bonus eligibility where applicable.
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