Pharma QA Reviewer: Batch Records & Compliance

Cipla; Hauppauge, Northern (NY, KY); Hybrid; USD 66,000 - 86,000; Full time

Benefits offered by this job

401(k) matching

Health insurance

PTO

Parental leave

Job summary

Cipla is seeking a Quality Assurance Associate (Reviewer) for DPI in Hauppauge, NY. The role focuses on reviewing batch production records to ensure GMP compliance and regulatory readiness, with responsibilities spanning review, documentation, and audits.

Ideal candidate holds a Bachelor’s degree in a related field and has 2–3 years in batch record review, with strong GMP knowledge and cross-functional collaboration skills.

Qualifications

• Bachelor’s degree in pharmacy, life sciences, chemistry, or related field.
• Minimum 2–3 years of batch record review or QA experience in the pharmaceutical industry.
• Strong knowledge of GMP and regulatory requirements (FDA, EMA).
• Excellent organization and cross‑department collaboration.

Responsibilities

• Review batch production records to ensure GMP compliance.
• Verify entries are signed and dated; resolve discrepancies.
• Ensure records meet FDA/EMA regulatory requirements.
• Review and revise BPRs, SOPs, and related documents.
• Assist audits by providing batch documentation and responding to queries.
• Suggest improvements to the batch review process.

Skills

Document management systems

Batch documentation issues

Regulatory inspections & audits

Attention to detail

Time management

Education

Bachelor’s degree in pharmacy or life sciences

Tools

Master Control

Job description

Cipla is seeking a Quality Assurance Associate (Reviewer) for DPI in Hauppauge, NY. The role focuses on reviewing batch production records to ensure GMP compliance and regulatory readiness, with responsibilities spanning review, documentation, and audits.

Ideal candidate holds a Bachelor’s degree in a related field and has 2–3 years in batch record review, with strong GMP knowledge and cross-functional collaboration skills.