Job Title: Compliance Specialist

Position Overview

The Compliance Specialist ensures that all pharmaceutical processes, documentation, and operations follow regulatory, quality, and safety standards. This role supports audits, maintains compliance documentation, and helps the organization meet FDA, GMP, and internal quality requirements.

Key Responsibilities: -

Ensure company operations comply with FDA, cGMP, GxP, and other regulatory guidelines.

Review and update SOPs, policies, and quality documentation.

Support internal and external audits, including FDA, ISO, and client audits.

Identify compliance gaps and assist in corrective and preventive actions (CAPA).

Maintain compliance logs, risk assessments, and audit reports.

Coordinate with QA, QC, Manufacturing, and Regulatory teams to resolve compliance issues.

Monitor changes in regulations and ensure company documentation stays current.

Required Skills & Qualifications: -

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

1–3+ years of experience in compliance, QA, or regulatory roles within pharmaceuticals.

Strong knowledge of FDA, cGMP, GxP, ICH guidelines.

Excellent documentation, auditing, and reporting skills.

Ability to identify issues, analyze risk, and support CAPA processes.

Good communication and collaboration skills.