JOB DESCRIPTIONPosition: Sr. Executive – Quality Assurance (QMS)

Department: Quality Assurance (QMS)
Location: Saharanpur
Experience: 4–8 Years
Qualification: B.Pharm / M.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology) or equivalent
Salary: ₹25,000–₹30,000 per month (Negotiable)

Roles, Responsibilities & Authorities

- Ensure compliance with ALCOA+ principles and maintain QMS documentation.
- Assist in preparation of product registration, variation, and renewal dossiers.
- Support calibration, qualification, and preventive maintenance activities for laboratory instruments.
- Assist in verification, validation, and change control activities.
- Participate in internal quality audits and ensure timely closure of audit observations.
- Maintain product recall documentation and assist in mock recall activities.
- Ensure compliance with GMP, GLP, WHO-GMP, Schedule M, and company SOPs.
- Operate and maintain analytical instruments such as HPLC, UV-Visible Spectrophotometer, Karl Fischer Titrator, and IR Spectrophotometer.
- Support regulatory inspections by preparing required documents and coordinating with relevant departments.
- Review and maintain specifications for raw materials, APIs, and packaging materials.
- Coordinate internal and external product testing activities.
- Assist in developing and maintaining QA/QC procedures and documentation.
- Record deviations,



participate in Root Cause Analysis (RCA), implement CAPA, and monitor timely closure.
- Assist in preparation of Annual Product Quality Review (APQR/PQR), trend analysis, and stability review reports.
- Support Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Water System Validation activities.
- Prepare, review, and maintain SOPs, formats, logs, and other quality documents as per QMS requirements.
- Coordinate with Production, QC, Warehouse, and Regulatory teams to ensure compliance with quality standards.

Required Skills

- Strong knowledge of QMS, GMP, GLP, WHO-GMP, and Schedule M.
- Good understanding of ALCOA+ and Data Integrity principles.
- Strong documentation and SOP preparation skills.
- Knowledge of Internal Audits and Audit Compliance.
- Hands-on understanding of CAPA, Deviation, RCA, and Change Control.
- Good communication and documentation skills.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Experience in pharmaceutical, herbal, Ayurvedic, or related regulated manufacturing environments will be preferred.

Perks

- Flexible Schedule
- Paid Sick Time
- Provident Fund (PF)

Work Location: In Person

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

- Versatile schedule
- Paid sick time
- Provident Fund

Work Location: In person

📌 Sr. Executive – Quality Assurance (QMS) (India)
🏢 natural herbs formulation
📍 India