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Quality Sr Specialist

4-10 years
Not Disclosed
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, 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 Title: Quality Systems Specialist
Company: TAPI (Teva Active Pharmaceutical Ingredients)

Company Overview:
TAPI is a global leader in the supply of Active Pharmaceutical Ingredients (APIs) with an extensive portfolio of over 350 products. The company serves 80% of the top 50 global pharmaceutical companies, with a legacy spanning over 80 years. TAPI operates state-of-the-art facilities worldwide, including in Israel, Italy, Hungary, the Czech Republic, Croatia, Mexico, and India. Through continuous investment in research and development, TAPI ensures the timely introduction of new products to the market, and is committed to maintaining its position as one of the most trusted API suppliers globally.

Role Overview:
The Quality Systems Specialist is responsible for managing and overseeing quality processes within TAPI, ensuring compliance with regulatory requirements and company standards. This role involves the collection, analysis, and review of data for the Annual Product Quality Review (APQR), processing changes related to documentation, reviewing validation processes, and supporting various quality metrics and training initiatives.

Key Responsibilities:

  • Data Collection & Analysis: Collect, compile, analyze, and review all data for the Annual Product Quality Review (APQR).
  • Change Control: Process and oversee changes through the entire workflow, including justification, impact assessment, modification, review, approval, and implementation.
  • Documentation Review: Review and approve documentation associated with process validation, continuous process verification (CPV), cleaning validation, and GMP equipment, including IQ, OQ, and PQ documents.
  • Quality Metrics: Track, trend, and report quality metrics for site, regional, and global reviews, ensuring compliance with SOPs, corporate standards, and regulations.
  • System Validation: Review documentation associated with the establishment and configuration of GMP computerized systems and all related lifecycle documents.
  • Regulatory Compliance: Review regulatory and quality compliance requirements and conduct gap assessments, establish or improve SOPs, and provide quality support to Regulatory Affairs.
  • Training Management: Manage GMP training programs, track performance, and support plant performance and departmental training.
  • Validation Master Plan: Review and approve the Validation Master Plan, including documentation related to the validation or qualification of processes, systems, equipment, facilities, and utilities.
  • Compliance Monitoring: Ensure adherence to regulatory requirements, divisional policies, and performance standards related to quality systems and GMP activities.

Qualifications and Experience:

  • Education: B.Sc. or M.Sc. in Chemistry or related field.
  • Experience: 4 to 10 years of experience in quality systems, process validation, GMP, and regulatory compliance in the pharmaceutical industry.
  • Skills:
    • Strong understanding of regulatory and GMP compliance requirements.
    • Experience with process validation, change control, and documentation management.
    • Ability to review and approve quality metrics, training, and validation plans.
    • Strong attention to detail and the ability to work independently and collaboratively.
    • Excellent communication skills, both verbal and written.

Teva’s Equal Employment Opportunity Commitment:
TAPI is an equal opportunity employer, committed to a diverse and inclusive workplace. The company values all candidates, regardless of race, age, gender, disability, or any other legally protected status. If you require accommodations during the recruitment process, TAPI will provide the necessary support to ensure an accessible experience.

Apply now to be part of a global leader in the pharmaceutical industry and help make a difference in healthcare!