Qara Officer Jobs

We are hiring a QARA with a Bachelor of Pharmacy and/or with pharmacist certification to become the technical PIC of the Registered Medical Devices in Indonesia, as well as help reviewing incoming, in- process and outgoing quality control records and any other QARA functions at Nalagenetics. The ideal candidate is someone who fluent in English (both writing and speaking), good analytical thinking and results oriented.

Previous exposure to ISO13485 and Good Distribution Practice for Medical Devices (GDPMDs) will be an advantage.

Key Responsibilities

• Maintain good communication and relationship with related regulatory bodies/organizations in Indonesia
• Become the technical PIC of the Registered Medical Devices in Indonesia (PJT Alat Kesehatan)
• Reviewing incoming, in-process and outgoing quality control records and final product release to customer
• Participate in the handling of product and process non-conformities including but not limited to investigation, CAPA and disposition of affected products
• Participate in the inter/intra-company transfers of new technology, products, processes, and methods
• Oversee legal and regulatory requirements with laboratory partners/collaborators
• Assist in compiling, reviewing, submitting and following up regulatory submissions and marketing authorization applications, where required
• Other duties as assigned
• Perform continuous monitoring, evaluation, and validation towards equipments and facilities for the registered medical devices in Indonesia
• Initiate, review, and implement document change requests in a timely manner
• Assist in writing and reviewing Quality Assurance SOPs
• Maintenance of document control system, including updating and obsoleting of SOPs, forms, logs and records, obtaining proper review and approval for documents
• Initiate and organize supplier assessment, qualification, and evaluation of supplier’s performance

Skills required

• Drive for results, sense of urgency, self – motivated to deliver high quality work on time, good teamwork.
• Good English proficiency (writing and speaking)
• Has ability on analytical thinking and good in details, openness to new ideas, resourceful, well – organized, cross-cultural competence.

Preferred Experience

1 – 2 year(s) of working experiences as Quality Assurance and/or Regulatory Affairs in healthcare business (preference on Medical device or diagnostic industry)

Minimum Education Qualification

Bachelor of Pharmacy and/or with pharmacist certification