Quality Control Documentation

Immacule Life Sciences; Solan; On-site; INR 450,000 - 650,000; Full time

Job summary

Immacule Life Sciences is seeking a QC Documentation Specialist to prepare, review, and control pharmaceutical QC records in a GMP-regulated environment. You will maintain specifications, analytical methods, SOPs, COA, and related docs, ensuring timely issuance, archival, and regulatory alignment.

The role requires strong knowledge of QC documentation, GDP/ALCOA+ data integrity, and experience with OOS/OOT, deviations, CAPA, and audit documentation.

Qualifications

• Strong knowledge of pharmaceutical QC documentation and GMP requirements.
• Understanding of GDP and ALCOA+ data integrity principles.
• Familiarity with analytical testing documentation and lab records.
• Experience with OOS/OOT, deviations, CAPA, change control, and audit documentation.

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 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 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.

Skills

QC Documentation

GMP Compliance

Data Integrity (ALCOA+)

Audits Support

Documentation Control

MS Office

Tools

MS Word

MS Excel

LIMS

QMS

eDMS

Job description

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.