QA Specialist

Job description:

Job Summary:

We are seeking a dedicated and detail-oriented Quality Assurance Specialist to join our team. The ideal candidate must have a solid background in the pharmaceutical industry and will be responsible for ensuring full compliance with Good Manufacturing Practices (GMP), regulatory standards, and company quality protocols. This role plays a key part in maintaining the integrity and quality of our products and processes.

Qualifications:

• Graduate of BS Pharmacy, Applied Science, or Chemical Engineering

– Must hold a bachelor's degree in Pharmacy, Applied Science, Chemical Engineering, or a closely related field, providing a solid foundation in scientific principles and technical knowledge relevant to pharmaceutical operations.

• Preferably with prior experience in QA/QC or regulatory functions within the pharmaceutical industry

– Candidates who have hands-on experience in Quality Assurance, Quality Control, or regulatory compliance in a pharmaceutical manufacturing environment are highly preferred, as this ensures familiarity with industry standards and requirements.

• Dossier preparation and regulatory submission experience is an advantage

– Exposure to preparing technical dossiers, handling documentation, and coordinating regulatory submissions to local or international agencies will be considered an added asset.

• Strong analytical, problem-solving, and critical thinking skills

– Must be capable of identifying issues, analyzing data, evaluating possible solutions, and making sound decisions to support the company's compliance and quality objectives.

• Excellent English communication skills, both written and verbal

– Should demonstrate strong proficiency in written and spoken English, with the ability to prepare accurate reports, draft professional correspondence, and communicate effectively with internal teams and external regulatory bodies.

• Computer literate, with proficiency in Microsoft Office tools

– Proficiency in MS Word, Excel, PowerPoint, and other Microsoft Office applications is required for documentation, reporting, and presentation of data in a clear and professional manner.

• Highly organized, detail-oriented, and capable of managing multiple tasks

– Must possess strong organizational skills with the ability to prioritize workload, handle multiple projects simultaneously, and maintain accuracy and attention to detail in all tasks.

• Self-motivated, goal-oriented, and able to work both independently and collaboratively

– Should be proactive, driven to achieve results, and capable of working efficiently on individual assignments while also being an effective team player in collaborative projects.

Key Responsibilities:

• Ensure compliance with GMP guidelines and internal quality standards across all operations
• Oversee regulatory submissions including FDA applications and product registrations
• Prepare, review, and maintain documentation related to QA activities, audits, and compliance reports
• Assist in identifying areas for improvement and participate in the implementation of corrective and preventive actions (CAPA)
• Draft and update Standard Operating Procedures (SOPs), training materials, and quality manuals
• Collaborate with cross-functional departments to resolve product and process-related quality issues
• Participate in internal audits, inspections, and continuous quality improvement initiatives

Job Types: Full-time, Fresh graduate

Work Location: In person