Title:  Specialist, Quality Assurance

Summary:

The QMS Specialist will ensure the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in accordance with regulatory requirements, industry standards, and company policies

1. QMS Development and Maintenance:
    - Develop, implement, and maintain QMS procedures, policies, and documentation.
    - Ensure alignment with regulatory requirements (e.g., GDP, GMP, FDA, EMA).
2. Quality Assurance and Compliance:
    - Conduct internal audits and assessments to ensure compliance with QMS and regulatory requirements.
    - Identify and address deviations, non-conformities, and corrective actions.
3. Training and Awareness:
    - Develop and deliver training programs for employees on QMS policies, procedures, and regulatory requirements.
    - Ensure awareness and understanding of QMS principles throughout the organization.
    -  Ensure training is executed as required for SOP revisions.
    - Monitor training completion rate, provide reports and trending accordingly.
4. Continuous Improvement
    - Analyze data, identify areas for improvement, and propose corrective actions.
5. Change Control
    - Collaborate with departments to implement changes and enhancements.
6. Documentation and Record-Keeping:
    - Maintain accurate, complete, and controlled QMS documentation.
    - Ensure compliance with document control procedures.
    - Control the creation, revision, approval, and distribution of all documents and records related to the quality management system.
    - Implement procedures for document and record retention, accessibility, storage, retrieval, and disposal.
    - Ensure that documents and records are accessible to those who need them and stored in appropriate conditions to prevent damage or loss.
7. Vendor Management:
    - Collaborate with suppliers, contractors, and third-party logistics providers to ensure QMS compliance.
    - Conduct supplier audits and assessments as needed.
8. Customer Complaints and Feedback:
    - Investigate and address customer complaints related to quality.
    - Implement corrective actions and preventive measures.
9. Other QA responsibilities:
    - Support manager in managing day-to-day operating expenditures against operating budgets to ensure efficient usage of resources; 
    - Support the implementation of quality policies, procedures and standards to ensure alignment to global DKSH quality policy and local/international quality standards;
    - Provide constructive recommendations to enhance policies, practices and processes related to quality assurance (QA), safety, health & environmental (SHE) and registration (REG);
    - Support external audits from suppliers and other regulatory bodies;
    - Other tasks to support proper execution of quality management systems.

Functional skills and knowledge  

 •    Demonstrate good knowledge of ISO 9001:2015 requirements. 
•    Demonstrate proficiencies in office productivity tools (e.g. MS SharePoint, MS Word and Adobe Acrobat) 
•    Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions.
•    Demonstrate fluency in local language and ideally in English, both written and spoken
 

Soft skills  

 •    Experience in coordinating with cross-functional teammates
•    Excellent organizational and communication skills.
•    Attention to detail and accuracy.
•    Experience in conducting training or communicating change.
 

 1. Education:
    - Bachelor's degree in Pharmacy, Quality Assurance, or related field.
2. Experience:
    - Minimum 3-5 years of experience in pharmaceutical quality assurance, regulatory affairs, or QMS.
    - Experience in warehousing and logistics operations desirable.
3. Knowledge and Skills:
    - Strong understanding of GDP, GMP, FDA, and WHO regulations.
    - Familiarity with QMS standards (ISO 9001, ISO 13485).
    - Excellent analytical, problem-solving, and communication skills.
    - Ability to work in a fast-paced environment.
4. Certifications:
    - Certified Quality Auditor (CQA) preferred.

Work experience    Preferably with experience in Pharmaceutical or Healthcare industry
 

#LI-JI1