Job Description

About the Role
We are looking for a motivated professional to join our Production Quality Management System (QMS) team in Oral Solid Dosage (OSD) manufacturing. This role is critical in ensuring that our production processes meet global regulatory standards, deliver consistent quality, and support continuous improvement across the plant.
Key Responsibilities
QMS Oversight
Implement and monitor QMS practices within OSD production.
Ensure compliance with GMP, USFDA, EMA, MHRA, and other regulatory requirements.
Review and approve SOPs, batch records, and deviation reports.
Production Support
Coordinate with production teams to ensure adherence to validated processes.
Monitor in-process controls and ensure timely resolution of deviations.
Support technology transfer and scale-up activities with QMS alignment.
Documentation & Compliance
Prepare for and support regulatory inspections and internal audits.
Drive data integrity and documentation accuracy across production operations.
Maintain accurate records of change controls, CAPA, and risk assessments.
Continuous Improvement
Identify opportunities for process optimization and efficiency enhancement.
Lead initiatives for error reduction, compliance strengthening, and productivity improvement.
Train production staff on QMS requirements and best practices.
Qualifications
B.Pharm / M.Pharm / B.Sc / M.Sc in Pharmaceutical Sciences or related field.
5-10 years of experience in OSD manufacturing with strong exposure to QMS.
Hands-on knowledge of GMP, regulatory guidelines, and audit readiness.
Experience in handling deviations, CAPA, change control, and risk management.
Strong understanding of OSD processes: granulation, compression, coating, packaging.

Skills Required