Quality Control Documentation

Role & responsibilities

• Prepare, review, maintain, and control QC-related documents and records.
• Manage QC documentation including specifications, analytical methods, SOPs, STPs, protocols, reports, logbooks, worksheets, and test records.
• Ensure timely issuance, retrieval, archival, and proper control of QC documents.
• Review analytical worksheets, test reports, raw data, and other QC records for completeness and compliance.
• Coordinate with QC analysts for timely completion and submission of analytical documentation.
• Ensure documentation practices comply with cGMP, GDP, ALCOA+ principles, and internal quality procedures.
• Support preparation and review of COA (Certificate of Analysis) and related quality documents.
• Maintain proper records of raw materials, packing materials, finished products, stability samples, in-process samples, and other QC activities.
• Assist in preparation and maintenance of specifications and analytical methods.
• Coordinate with QA/QC teams for document revisions, change controls, deviations, CAPA, OOS/OOT investigations, and related documentation.
• Support internal, customer, and regulatory audits by providing required QC documents and records.
• Ensure proper implementation and documentation of document revisions and obsolete-document control.
• Maintain document trackers and provide periodic status reports to management.
• Ensure QC records are properly archived and readily retrievable as per retention requirements.
• Follow applicable SOPs, safety requirements, and pharmaceutical quality systems.

Preferred candidate profile

• Good knowledge of pharmaceutical QC documentation and GMP requirements.
• Understanding of GDP and ALCOA+ data integrity principles.
• Knowledge of analytical testing documentation and laboratory records.
• Familiarity with OOS/OOT, deviations, CAPA, change control, and audit documentation.
• Good documentation, coordination, and follow-up skills.
• Strong attention to detail and accuracy.
• Good communication and interpersonal skills.
• Working knowledge of MS Office, particularly Word and Excel.
• Experience with LIMS / QMS / eDMS will be an added advantage.

Preferred Candidate Profile

• 3-5 years of relevant experience in QC Documentation / Quality Control within a pharmaceutical formulation manufacturing environment.
• Experience in handling QC documentation in a cGMP-compliant pharmaceutical organization.
• Candidates with exposure to regulatory/customer audits and data integrity requirements will be preferred.
• Should be organized, detail-oriented, and capable of managing multiple documentation activities within timelines.