- Ensure compliance of commercial site to local and relevant Division quality and regulatory requirements with guidance/support from Regional team
- Monitor and ensure release for sale of all products which conform to Abbott and local regulatory requirements and specifications.
- Develop and maintain Quality Agreements and records for all Third-Party Manufacturer (TPM) sites. Approve or reject products over-labeled by TPMs by reviewing and auditing of batch relevant documentations.
- Management of product complaint processes. Liaise with business and manufacturing plants for complaint investigation and relevant CAPA implementation with guidance/support from Regional team.
- Coordinate and implement product field actions with guidance/support from Regional team (recalls, safety alerts etc.).
- Ensure Quality Systems are in place that meet the requirements for business needs, local regulatory authorities and Abbott Quality Assurance.
- Provide guidance and advice, as requested, on the development and implementation of quality systems in the relevant departments in Abbott Products Indonesia with guidance/support from Regional team
- Develop, review, release, and maintain Quality System Related SOPs.
- Coordinating, organizing, and/or executing/ supervising all internal and external audits of Abbott (Country) (AN) with guidance/support from Regional team
- Coordinate with business teams for all post auditing activities and lead, drive the execution of corrective actions and preventive actions, ensuring the timely closure of CAPA actions with guidance/support from Regional team
- Perform Management Review and propose initiatives for quality performance improvement with guidance/support from Regional team
- Facilitate to ensure Quality management of Distributors per request.
- Provide or coordinate training on Quality Assurance requirements with guidance/support from Regional team
- Support and implement Division Quality projects for local site.
- Minimum Bachelor degree in Life Science, Pharmacy or Nutrition/Food related discipline.
- Prefer 3 or more years working in the quality management or related filed or positions.
- Good communication skill in Bahasa Indonesia and English