Executive - Quality Control Documentation

Why This Role Matters

Quality Control documentation ensures traceability, data integrity, and regulatory compliance in pharmaceutical testing laboratories. Accurate and well-controlled documentation supports batch release decisions, audit readiness, and regulatory submissions.
At APDM Pharmaceuticals, the Officer / Sr. Officer / Executive / Sr. Executive – QC Documentation plays a critical role in managing laboratory records, specifications, analytical reports, and compliance documentation at the Sakodara, Gujarat facility. This role directly contributes to maintaining inspection readiness and ensuring adherence to GMP and data integrity principles.

Job Description

APDM Pharmaceuticals is seeking qualified professionals with 2 to 5 years of pharmaceutical Quality Control documentation experience. The selected candidate will be responsible for preparation, review, control, and archival of QC documents including STPs, specifications, analytical reports, and logbooks.
The role requires strong knowledge of laboratory documentation practices, regulatory guidelines, and Good Documentation Practices (GDP). The candidate will work closely with QC analysts, QA, and production teams to ensure accuracy and completeness of records.

Key Features of the Role

• Core responsibility in QC documentation control
• Exposure to specification and STP preparation
• Involvement in OOS, OOT, and investigation documentation
• Participation in audit and inspection readiness
• Handling of document lifecycle management
• Career growth within QC or Quality Systems

Responsibilities

• Prepare, review, and control Standard Testing Procedures (STPs)
• Draft and revise specifications for raw materials, in-process, and finished products
• Review analytical reports and laboratory raw data for accuracy
• Maintain logbooks, registers, and laboratory documentation records
• Ensure compliance with Good Documentation Practices (GDP)
• Support OOS, OOT, deviation, and investigation documentation
• Coordinate with QA for document approval and control
• Manage document archival and retrieval systems
• Ensure data integrity compliance in laboratory documentation
• Assist during internal audits and regulatory inspections
• Track document revisions and maintain version control

Required Qualifications

• 2 to 5 years of experience in pharmaceutical QC documentation
• Strong understanding of GMP and laboratory documentation practices
• Experience in STP and specification preparation
• Knowledge of OOS and deviation documentation handling
• Familiarity with data integrity principles

Educational Requirements

• M.Sc in Chemistry / Analytical Chemistry
• M.Pharm preferred
• Strong academic background in pharmaceutical or analytical sciences

Experience and Skills

• Hands-on experience in QC documentation control
• Strong attention to detail and accuracy
• Knowledge of regulatory expectations for laboratory compliance
• Familiarity with analytical instruments documentation (HPLC, GC, etc.)
• Good communication and coordination skills
• Ability to manage multiple documentation tasks within timelines
• Basic knowledge of ERP or Laboratory Information Management Systems preferred

Salary Insights

• Performance-based appraisal structure
• Exposure to regulated pharmaceutical laboratory environment
• Growth opportunities toward Assistant Manager – QC or Quality Systems

Company Overview

APDM Pharmaceuticals is a growing pharmaceutical organization committed to delivering high-quality healthcare solutions. Operating from its manufacturing facility in Sakodara, Gujarat, the company emphasizes regulatory compliance, data integrity, and operational excellence.
The organization provides a structured and growth-oriented environment for professionals seeking long-term careers in Quality Control and Quality Systems.

FAQs

Q: Is laboratory experience mandatory for this role?
Yes, candidates must have prior QC documentation or laboratory experience in a pharmaceutical setting.

Q: Will the role involve instrument handling?
The primary focus is documentation, but exposure to analytical instruments documentation is preferred.

Q: Is audit exposure required?
Audit participation is preferred but not mandatory.

Q: What determines Officer vs. Executive level?
Experience depth, independent documentation handling, and regulatory exposure determine the designation.

Application Tips

• Clearly mention STP and specification drafting experience
• Highlight OOS, OOT, and deviation documentation exposure
• Include audit participation details
• Mention instruments worked with (HPLC, GC, UV, etc.)
• Quantify documentation volume handled per month
• Showcase data integrity and GDP compliance experience