QA / Regulatory Officer

12 hours ago

Pasig, National Capital Region, Philippines Oxford Distributions, Inc. Full time $104,000 - $130,878 per year

DUTIES AND RESPONSIBILITIES: Works together with the VP-Operations in the following key functions:·

Ensuring all products and pharmaceutical companies distributed by the company follows FDA regulations·

Effective implementation of Complaints Management Program·

Effective implementation of Supplier Quality Program·

Effective implementation of Documentation Management Program·

Effective implementation of Change Control Management Program·

Effective implementation of Incident and Crisis Management Program (i.e. Product Recall, Adverse Event, Business Continuity Plan, etc.)·

Attends to Principals and Third Party Auditors·

Provides relevant quality training to process owners on quality requirements (ISO, GSDP, Regulatory, Cold Chain, etc.).·

Control of Documents·

Monitoring (Receipt, Storage, Pick/Pack) of Regulated Drugs and reportorials to PDEA·

Review and analysis of Deviation Reports·

Review of CAPA raised to warehouse and distribution operations·

Monitors Re-packing/Redressing Operations in the warehouse and coordination with principals·

Other tasks assigned by VP-Operations from time to time. System Management·

May be assigned in systems management projects which will require working with a team on review of processes, data collection and analysis and identification of risks. Depending on the assigned project, the work will involve: 1) making recommendations to improve controls and ensure compliance to company policies and relevant standards and/or 2) developing policies, standards and procedures for operations and systems in ODI QUALIFICATIONS:

  • Minimum of three years of solid experience in quality function (particularly on Quality Systems/ Programs execution, conducting and managing internal/external audits)
  • Preferably with 2 years experience gained in a multinational manufacturing company (pharmaceutical, consumer or food manufacturer)
  • Good knowledge of QA/QC theory, principles, practice and techniques
  • Good knowledge of Good Manufacturing Practices (GMP) / Good Warehousing Practices (GWP) / Good Storage and Distribution Practices (GSDP)
  • Must be trained in ISO 9001:2008 Quality Management Systems

  • Direct experience in warehousing and distribution is a distinct advantage.

  • Must be a Registered Pharmacist

  • Must have good working knowledge of MS Office (especially on Word, Excel and PowerPoint)

  • Must have good oral and written communications skills.
  • Must have initiative and good judgment.
  • Must have good planning and organizational skills.
  • Must be approachable and flexible.
  • Must be proactive and good leader.
  • Must be organized and systematic in handling schedules and workflows.

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