Theresia .

Experience

• 

  PT. Actavis Indonesia

  Jul 2008 - Jun 2011

  QA Release Officer

  - Review Batch record prior to release- Ensure the completeness of batch record prior to release- Batch record filling

• 

  PT. Pfizer Indonesia

  Jun 2011 - Jul 2015

  - Coordinate and supervise daily activities of in-process control and packaging line inspection of manufactured products- Coordinate and supervise daily activities of sampling and evaluation of packaging materials, imported products and non inventory materials- Providing data for annual product review, trending of material complaint, deviation/non conformance, and product quality complaint- Review Packaging Material Specification- Review calibration and maintenance report/documents- Supervise retention sample and batch records filling and destruction activities Show less

  • Quality Assurance Spv.

    Oct 2012 - Jul 2015

  • Quality Assurance Specialist

    Jun 2011 - Sept 2012
• 

  PT. MAHAKAM BETA FARMA

  Aug 2015 - now

  - Review and revise SOPs of Quality Assurance to comply with the current GMP- Conduct detailed assessment of the existing Quality Systems for regulatory compliance and current GMP - Evaluate the investigation reports of Manufacturing, Packaging and Quality Control on questionable batches / results for regulatory compliance and current GMP- Finished product disposition- Coordinate product recall activity with distributor and related departemen- Conduct internal and external audit- Manage CAPA from BPOM and toll in manufacturers audit findings - Create Quality Agreement for toll in/out manufacturing- Coordinate the implementation of post market stability, Product Quality Report (PQR) and customer satisfaction survey Show less

  • QC Manager

    Aug 2018 - now

  • QA Assistant Manager

    Aug 2015 - now