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Quality Assurance Specialist

Crystal Pharmatech
1-3 years
Not Disclosed
15 June 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

The Quality Assurance Specialist will report to the Head of Small Molecule Division. The candidate will be in charge of all quality assurance activities at the site, including maintenance of the SOPs, site preparation for client audits, review of GMP data, quality training of the R&D personnel. Maximum of 5 work hours per day is required. This is a contractor position with possibility of converting to a part-time employee on business needs.

 

The ideal candidate should have the following qualifications:

  • B. Sc. in Chemistry, or related field
  • 1-3 years pharmaceutical industry experience in a QA role
  • Strong interpersonal skills required to effectively collaborate with the R&D team and clients
  • Very good understanding of the GMP requirements

 

Roles and Responsibilities

· Maintenance of the QMS:

o SOP periodic review

o Change control

o Instruments IQ/OQ

o Quality training of the R&D personnel.

o Site preparation for client’s audits