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.

- Valuable 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.

📌 Quality Control Documentation (Nalagarh)
🏢 Immacule Life Sciences
📍 Nalagarh