Quality Assurance Executive
About the Employer
Job Description
WE ARE HIRING!
PREMIUM INTERNATIONAL INJECTABLE (PVT) LTD
Career Opportunity
We are a sterile Pharmaceutical Manufacturing Company looking for a young energetic individual with pristine qualifications and experience to take the lead in the following position. The project is at the development stage and is located in BOI, Export Processing Zone, Koggala.
QUALITY ASSURANCE EXECUTIVE (QMS/IPQA/VALIDATION)
Roles and Responsibilities
- Manage and maintain QMS elements including CAPA, deviations, change controls, and audits.
- Ensure compliance with GMP, regulatory requirements, and internal quality standards.
- Support regulatory inspections and ensure audit readiness.
- Perform line clearance, in-process checks, and batch record review.
- Monitor critical manufacturing activities to ensure compliance with approved procedures.
- Coordinate closely with Production and QC for real-time quality assurance.
- Support execution of process validation, cleaning validation, and aseptic process simulation (media fills).
- Review validation protocols, reports, and qualification documents (IQ/OQ/PQ).
- Ensure validation activities meet regulatory and data integrity requirements.
- Prepare, review, and maintain SOPs, BMRs, BPRs, and validation documents.
- Ensure effective document control and data integrity practices.
- Support APQR/PQR and batch release activities.
- Conduct GMP and QMS training programs.
- Contribute to continuous improvement initiatives and quality culture development.
Qualifications & Requirement
- Bachelor’s Degree in Pharmacy, Bio Science, Physical science or related field.
- Minimum 3 years of experience in pharmaceutical Quality Assurance.
- Strong 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.
Email: [email protected]
The successful candidate would receive a competitive remuneration package and other benefits. If you meet the required criteria, please email your CV, including contact details of two non-related referees to reach us within 07 days of this advertisement.
