Premium International Injectable (Pvt) Ltd

Role Summary

We are a sterile Pharmaceutical Manufacturing Company looking for a young energetic individual with pristine qualifications and experience to take the lead as a Quality Assurance Officer (QMS/IPQA/Validation). The project is at the development stage.

Key Responsibilities

• Develop, execute, and document process and equipment validation protocols.
• Perform sampling activities and actively participate in risk assessments, as well as FAT/SAT processes.
• Monitor environmental conditions and ensure accurate and compliant documentation practices.
• Manage deviations, CAPA processes, and quality reporting in accordance with established QMS standards.
• Verify and inspect utility systems, including AHU installations, duct integrity (leak tests), and equipment setup.
• Prepare, maintain, and control QA documentation such as SOPs, Protocols, Risk assessment etc.
• Support training initiatives and ensure proper maintenance of training records.
• Participate in internal and external audits, assist in APQR preparation, and ensure compliance with GMP requirements.
• Maintain QA archives and support documentation management activities.

Requirements/Qualifications

• Bachelor’s Degree in Pharmacy, Bio Science, Physical science or related field.
• 1-3 years of experience in pharmaceutical Quality Assurance.
• Hands-on experience in QMS, IPQA, and validation activities.
• Sound knowledge of GMP, data integrity, and regulatory expectations (EU/WHO/PIC/S).
• Experience in sterile manufacturing environments will be a strong advantage.
• High level of computer literacy, including window-based systems & MS Office Package.

Location

Factory: Board of Investment (BOI), Export Processing Zone, Koggala, Sri Lanka.

Salary/Benefits

The successful candidate will receive a competitive remuneration package and other benefits.