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Offers “Abbott”

Expires soon Abbott

Quality Assurance Supervisor

  • INDONESIA
  • Design / Civil engineering / Industrial engineering

Job description

JOB DESCRIPTION:

  • 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.

JOB QUALIFICATIONS:

  • 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

JOB FAMILY:

Regulatory Operations

DIVISION:

ANI International Nutrition

LOCATION:

Indonesia > Pondok Indah : Wisma Pondok Indah 2

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)