QA STAFF/ PHARMACIST (1) (ARKRAY Industry, Inc.)

Job Description:

* Preferably graduate of PHARMACY or Allied Courses or any 4-year courses; * with at least 6 months working experience Fresh Graduates may be considered; * Working knowledge on ISO 13485 and FDA is an advantage

Requirements

  • Licensed, Graduate of Pharmacy or Allied Courses or any 4-year Courses
  • With at least 6 months working experience
  • Skills Required

  • Qualified auditor or has experience with QMS Audits
  • Preferably with experience in US FDA audits handling
  • Ability to write QMS procedures and can judge suitability of working instructions and procedures
  • Proficient in communication skills both written and oral
  • Duties and Responsibilities

  • Prepares necessary documents for the approval of application and compliances with government authorities such as PDEA, FDA, BFAD ensuring timely submission.
  • Liaises with FDA and other agencies for product registration and other concerns.
  • Monitors validity of documents required by the business such as Licenses, Certifications, permits etc.
  • Maintains and renew certificates of product registration of existing products.
  • Files amendments/variations with FDA as may necessary.
  • Updates and disseminate information to all concerned department on the latest regulations and circular as need arises.
  • Performs necessary inspection in coordination with Team concerned on matter that may affect transaction with government agencies.
  • Creates and revises Standard Operating Procedures used by the company for operations under Regulatory.
  • Assists in the internal audits or 3rd party audits and closure of audit findings.
  • Conducts training in relations to quality management systems.
  • Assists immediate superior in the continual review of internal processes and procedures.
  • Performs other jobs that maybe assigned by immediate superior from time to time.
  • Office Location

    Lot 22 Phase 1A, First Philippine Industrial Park, Sta. Anastacia, Sto. Tomas, Batangas