PHARMACEUTICAL QA/QC SPECIALIST

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Berikut informasi kerja PHARMACEUTICAL QA/QC SPECIALIST yang dipublikasikan pada April 06, 2016 at 06:33PM. Silahkan anda simak untuk syarat, kualifikasi dan data pendukung yang diperlukan.

Post Date 06-Apr-16

jobsDB Ref. JID200003001566948

Employer Ref. RN120116

The Pharmaceutical Quality Assurance/Quality Control Specialist will the implementation of the USP PQM work plan activities in Indonesia 

DUTY STATION: , Indonesia with travel in Indonesia

REPORTS TO: Indonesia of Party

MAIN RESPONSIBILITIES:

  • Provide ongoing training and technical assistance support to BPOM and other quality control laboratories in Indonesia on basic and compendial testing under the USP PQM .
  • Provide assistance to BPOM staff at National and Provincial Lab on drafting and review and implementation of their SOP or written procedures.
  • Provide assistance and support BPOM staff at National and Provincial Lab on implementation of Quality Management System
  • Coordinate activities under GFATM support, including liaising with national TB and AIDS programs, BINFAR, and BPOM
  • Support CoP and USP PQM QA/QC management and staff to implement TB and HIV work plans including conducting sampling and testing of medicines throughout supply chain.
  • Travel to central or provincial BPOM and BBPOM QC labs as needed for training, follow-up, and project implementation.
  • Provide troubleshooting for equipment and systems used in compendial testing of medicines (HPLC, LC-MS MS, UV, KF titration, dissolution, etc.).
  • Conduct pre-assessment and support the USP Expert on assessment in provincial lab.
  • Coordinates activities for visiting USP experts, consultants, and scientists
  • Supports Logistic and Procurement Officer on procurement activities
  • Support and follow up Corrective and Preventive Action reports of assessment to improve the capabilities of provincial QC Lab
  • May be expected to provide inputs into GMP-related activities
  • Support CoP establish the work plan implementation and report annually
  • Prepares documents and reports in and Bahasa for submission to supervisor, partners and donors
  • Works effectively as a member of a small country office team
  • Performs other duties as assigned

MINIMUM REQUIRED QUALIFICATIONS:

Education:

  • S1-level Bachelor degree in Pharmacy, Chemistry, or related field with 3 years’ experience or in Quality Control activities in the pharmaceutical industry or regulatory environments.

Required Experience:

  • Minimum two or three years’ experience working in a pharmaceutical QC laboratory
  • Proficiency on at least three major analytical methods; HPLC, GC, LC-MS, GC-MS, UV, KF titration and dissolution
  • Experience with providing education or training on advanced compendial testing of medicines such as HPLC, GC and dissolution.
  • Experience with validation and verification test method according to compendial standard.
  • Experience with developing Quality Management Systems for QC laboratories, ISO/IEC 17025 requirements, SOPs, Quality Manual, etc.
  • Experience with auditing, monitoring and evaluation
  • Preferred work experience in a USAID or other international donor-funded project in Indonesia is preferred
  • Effective communication skills as a team player, and experience with project implementation at national and local levels
  • Fluency in Bahasa Indonesia and proficiency in written and oral English required

 

Career Level Middle
Yr(s) of Exp 2 years
Qualification Degree
Industry Medical / Pharmaceutical
Job Function Sciences / Laboratory / R&D > Chemical
Medical Services > Pharmaceutical
Manufacturing > Quality Assurance, Control & Testing / ISO
Location DKI Jakarta
Salary Salary negotiable
Employment Type Full Time

Keywords:PHARMACEUTICAL QA/QC SPECIALIST 

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