QA Associate IT - DPI

Cipla•Hauppauge, NY

2d•Onsite

About The Position

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.

Requirements

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.
Bachelor’s degree in pharmacy, Life Sciences, Chemistry, or a related field.
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.

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.