QA Officer - Premium International Injectable (Pvt) Ltd

Premium International Injectable (Pvt) Ltd
Koggala, Sri Lanka
Job Category: R&D & Science

QA Officer

ENSURE PHARMACEUTICAL EXCELLENCE IN A STERILE MANUFACTURING ENVIRONMENT!

Premium International Injectable (Pvt) Ltd is a sterile Pharmaceutical Manufacturing Company seeking a young, energetic individual with pristine qualifications and experience to join our team as a QA Officer. This is a unique opportunity to be part of a project at its development stage, located in the BOI, Export Processing Zone, Koggala.

As a QA Officer, you'll play a critical role in ensuring that all manufacturing processes and products adhere to the highest quality standards and regulatory requirements in the pharmaceutical industry.

Roles and Responsibilities:

• Prepare and execute process and equipment validation protocols to ensure operational efficiency and compliance.
• Collect samples and actively participate in risk assessments and FAT (Factory Acceptance Test)/SAT (Site Acceptance Test) processes.
• Monitor environmental conditions within the manufacturing facility and ensure meticulous documentation accuracy.
• Handle deviation reports, CAPA (Corrective and Preventive Actions), and comprehensive quality reporting in alignment with stringent Quality Management System (QMS) standards.
• Verify utility systems, including AHU (Air Handling Unit) placement, conduct duct leak tests, and ensure proper equipment installation.
• Review batch records meticulously and assist in batch release procedures and ERP (Enterprise Resource Planning) system updates.
• Maintain and issue essential QA documentation, including SOPs (Standard Operating Procedures), logbooks, and BMR (Batch Manufacturing Record)/BPR (Batch Packing Record).
• Support the development and execution of internal training plans and maintain accurate training records.
• Actively participate in internal and external audits, assist in APQR (Annual Product Quality Review) preparation, and ensure continuous compliance with GMP (Good Manufacturing Practices) requirements.
• Assist in organizing training programs for personnel and maintain organized QA archives.
• Execute any other QA responsibilities as assigned by the Head of Department (HOD).

Qualifications & Requirements:

• Bachelor's Degree in Pharmacy, Chemistry, Life Sciences, or Biotechnology (B.Pharm / B.Sc.).
• 2-3 years of proven experience in a QA role within the pharmaceutical or a related sterile manufacturing industry.
• Basic understanding of validation protocols, GMP requirements, and efficient document handling practices.

The successful candidate will receive a competitive remuneration package and other attractive benefits. If you meet the required criteria, please email your comprehensive CV, including contact details of two non-related referees, to careers@premiuminjectables.com.

Premium International Injectable (Pvt) Ltd
258, Havelock Road, Colombo 05

Closing Date: August 6, 2025

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The Critical Role of Quality Assurance in Sri Lanka's Pharmaceutical Industry

Sri Lanka's pharmaceutical industry is a rapidly evolving sector, dedicated to ensuring the availability of safe, effective, and high-quality medicines. At the heart of this commitment lies Quality Assurance (QA), a critical function that oversees every stage of pharmaceutical manufacturing, from raw material sourcing to final product release. QA professionals are instrumental in upholding international standards like Good Manufacturing Practices (GMP), safeguarding public health, and maintaining the integrity of pharmaceutical products.

A career in pharmaceutical QA in Sri Lanka offers a vital role in a highly regulated and impactful industry, demanding meticulous attention to detail, strong analytical skills, and an unwavering commitment to quality and compliance.

Why a QA Officer Role in Sterile Pharmaceutical Manufacturing?

• High Impact: Directly contribute to patient safety and the efficacy of life-saving injectable products.
• Specialized Knowledge: Gain expertise in sterile manufacturing processes, an advanced area within pharmaceuticals.
• Regulatory Compliance: Work extensively with global GMP standards, validation protocols, and quality management systems, building highly sought-after skills.
• Holistic View: Understand the entire product lifecycle from development to batch release and post-market activities.
• Growth Opportunities: The pharmaceutical sector is continuously expanding, offering strong career progression paths for QA professionals.

Tips for Excelling as a QA Officer:

To excel as a QA Officer in the pharmaceutical industry, particularly in a sterile manufacturing environment, a meticulous eye for detail is paramount. Develop a deep understanding of GMP regulations and how they apply to every aspect of production. Familiarize yourself with various validation processes (process, equipment, utility) and their documentation requirements. Strong analytical and problem-solving skills are crucial for conducting risk assessments, handling deviations, and implementing CAPAs. Become proficient in document control and record-keeping, as accurate and comprehensive documentation is the backbone of QA.

Effective communication skills are also vital for collaborating with production, R&D, and regulatory teams, as well as for participating in audits. Proactively seek opportunities to learn about new technologies, industry guidelines, and quality trends to stay ahead in this dynamic field. Your dedication to upholding quality will directly impact product safety and patient trust.

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Don't forget to regularly check our main job portal for the latest vacancies across various sectors in Sri Lanka. For in-depth articles on resume building, interview preparation, and industry trends, Read our Career Guidance Articles.