Documentation & QA Executive

Job Opening: Documentation & QA Executive – Pharmaceutical Manufacturing

Industry: Pharmaceutical Manufacturing

Experience: 2–5 Years

Qualification: B.Pharm / D.Pharm / B.Sc. / M.Sc. (Relevant Science Discipline)

Department: Quality Assurance / Documentation

Employment Type: Full-Time

Location: Baddi, HP

Key Responsibilities (KRAs)The selected candidate will be responsible for the following:

Manufacturing Documentation:

• Prepare, review, and maintain Batch Manufacturing Records (BMR).
• Ensure accurate and timely BMR filling in compliance with GMP and SOP requirements.
• Review and ensure completeness of Batch Packaging Records (BPR).
• Maintain proper documentation related to daily manufacturing activities.
• Verify the accuracy and completeness of manufacturing records before submission.

Documentation Control:

• Prepare, revise, issue, and control standard documentation formats.
• Design, update, and implement documentation formats as per regulatory requirements.
• Maintain document version control and ensure only current documents are in circulation.
• Maintain documentation registers, logs, and records in an organized manner.

Artwork Management

• Coordinate artwork development and revisions for packaging materials.
• Review artwork for regulatory and product compliance.
• Obtain necessary approvals from internal stakeholders.
• Maintain artwork approval records and version history.

Log Book Management:

• Maintain equipment, process, and department log books.
• Ensure entries are complete, accurate, and made in a timely manner.
• Periodically review log books for compliance and record integrity.

Quality Assurance Support:

• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Standard Operating Procedures (SOPs).
• Assist during internal and external audits by providing required documentation.
• Coordinate with Production, Quality Control, Regulatory Affairs, and other departments for documentation-related activities.
• Support implementation of corrective and preventive actions (CAPA) related to documentation.

Required Qualifications:

• B.Pharm / D.Pharm / B.Sc. / M.Sc. in Pharmacy or relevant Life Sciences.
• Minimum 2–5 years of experience in a pharmaceutical manufacturing environment.
• Hands-on experience in BMR, BPR, GMP documentation, and quality assurance documentation.

Required Skills:

• Strong understanding of GMP, GDP, and pharmaceutical documentation practices.
• Experience in preparation, review, and control of manufacturing documents.
• Knowledge of artwork approval processes.
• Excellent documentation and record management skills.
• High attention to detail and accuracy.
• Good communication and coordination skills.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Preferred Candidate Profile:

• Experience working in a regulated pharmaceutical manufacturing facility.
• Ability to work independently while coordinating with cross-functional teams.
• Strong analytical and organizational abilities.
• Commitment to maintaining documentation accuracy and regulatory compliance.