QC Raw Material Release

QC Raw Material Release

Job Description:

We are seeking a highly skilled and motivated Quality Control Subject Matter Expert (SME) to lead and support raw materials release activities within our operations.

This role is pivotal in ensuring the integrity, compliance, and timely availability of raw materials for manufacturing, while driving continuous improvement and cross-functional alignment across quality, supply chain, and technical operations.

Key Responsibilities:

Technical Leadership

Serve as the SME for raw material testing, specifications, and release processes.

Provide guidance on analytical methods, pharmacopeial standards.

Lead troubleshooting and investigations related to raw material quality issues.

Quality Oversight & Compliance

Ensure all raw materials meet internal and external quality standards prior to release.

Manage and support risk assessments and deviations related to raw materials.

Review and approve Certificates of Analysis (CoAs), test results, and documentation.

Support audits and inspections by regulatory authorities and clients.

Cross-Functional Collaboration

Partner with Procurement, Supply Chain, Manufacturing, and QA to ensure seamless material flow.

Collaborate on risk assessments and change control evaluations for new or revised raw materials.

Continuous Improvement & Strategy

Identify and implement process improvements in sampling, testing, and release workflows.

Contributes to raw material lifecycle management.

Support digitalization and data integrity efforts within the QC function.

Qualifications:

At least bachelor's degree in chemistry/ Life Sciences or related field.

2+ years of experience in pharmaceutical QC, with a focus on raw materials.

Strong knowledge of GMP.

Proven ability to lead cross-functional initiatives and hands on approach.

Excellent communication, problem-solving, and organizational skills.

Familiarity with risk-based approaches to material qualification and release.

Advantage - Exposure to sterile or biologics manufacturing environments.