Job Description

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: $72,800-$93,600
Work Hours/Shift: 8:30AM - 5:00PM
Job Overview: The QA Associate (IT) is responsible for review of batch production records, ensuring that all documentation complies with Good Manufacturing Practices (GMP), regulatory standards, and internal quality assurance procedures. This role ensures the integrity, accuracy, and completeness of batch records related to pharmaceutical manufacturing processes, providing assurance that products are produced according to the approved methods and specifications.
Responsibilities:

• Review batch production records (BPRs), including associated documents (e.g., manufacturing instructions, protocols, and equipment logs), to ensure they are complete, accurate, and compliant with GMP and regulatory guidelines.
• Verify that all entries are properly documented, signed, and dated by the relevant personnel, and ensure that any discrepancies are resolved before approval.
• Ensure batch records and associated documentation meet regulatory requirements from agencies such as the FDA, EMA, and other relevant authorities.
• Review, creation and revision of BPRs, SOPs, and other documents related to manufacturing processes.
• Ensure batch records are audit-ready and fully compliant for both internal and external audits (e.g., FDA, GMP inspections).
• Assist audit teams by providing required batch documentation and responding to audit queries related to manufacturing processes and batch records
• Recommend process improvements to enhance the batch review process, reduce review time, and ensure better compliance.
• Address any issues or concerns related to batch records raised by cross-functional teams and ensure timely resolution.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's.
• Review of engineering records (temperature and humidity data, calibration reports and PMP records).
• To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
• 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:

• Familiarity with document management systems (e.g., Master Control).
• Ability to analyze and resolve batch documentation issues in a timely and efficient manner.
• Experience in preparing for regulatory inspections and audits.
• Excellent organization skills with the ability to focus on details
• Strong organizational and time-management skills to handle multiple batch reviews simultaneously.

Educational Qualification:
Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field.
Work Experience:

• Minimum 2-3 years of experience in batch record review or quality assurance in the pharmaceutical industry.
• Strong knowledge of GMP, regulatory requirements (FDA, EMA), and pharmaceutical manufacturing processes.
• High attention to detail and accuracy in reviewing complex documentation.
• Strong communication skills and the ability to collaborate effectively across departments.

About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc.
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 Cipla's respiratory business in the United States.
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 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.

Skills Required