QA Specialist
5 days ago
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
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