QA Specialist

1 day ago

San Pedro, Calabarzon, Philippines Private Advertiser Full time $40,000 - $60,000 per year

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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