Team Member - Quality Control

About the Role

This position involves preparing, updating, and reviewing specifications, SOPs, policies, and operating documents concerning material analysis to ensure quality alignment with standards, pharmacopeia, and current Good Manufacturing Practices (cGMP).

Key Responsibilities

• Develop and revise corporate documents like SOPs and analytical methods by collaborating closely with site QC and QA teams.
• Monitor pharmacopoeial and regulatory guidelines to implement timely updates in documents ensuring compliance.
• Review instrument calibration records relative to operating documents to maintain accuracy.
• Review new or updated monographs ensuring all documents reflect the latest pharmacopeial changes and coordinate these changes with regulatory bodies.
• Ensure timely communication and escalation of non-conformities to prevent operational delays.
• Perform thorough document reviews against quality standards and approved company policies to maintain consistency.
• Identify and resolve issues or queries during document revision, taking initiative to avoid delays.
• Issue documents and bound books to relevant units, maintaining accurate issuance records for accessibility of current versions.
• Lead efforts in process simplification and harmonization of documents to standardize procedures across units.
• Collaborate with cross-functional teams to facilitate work simplification and explore innovative solutions.
• Coordinate with CDC, QC, QA, Regulatory Affairs, R&D, and IPD teams for approvals and data necessary for document updates.
• Manage documentation workload supporting four units, handling about 10 document preparations or reviews monthly, aiming to finalize at least 80% within deadlines.

Challenges

• Addressing delays due to unavailable verification data by coordinating with QC.
• Managing time constraints caused by late notifications and shifting priorities through proactive planning and coordination.
• Ensuring timely feedback from cross-functional departments via regular follow-ups and escalation to meet deadlines.

Qualifications and Experience

Applicants must hold an M.Sc. or B. Pharma degree and possess 1-3 years of experience in the Quality Control department within the pharmaceutical industry, with familiarity of regulatory standards and compliance requirements.