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Job Details

All Jobs / Req# NOVRJP00011325
Req Number:
NOVRJP00011325
Req Title:
Country Quality Associate
Client:
A Major Pharma Company
Work Address:
Indianapolis, IN
Req Release Date:
03/29/2024
Duration:
6 months
Hours a week:
40 Hours
Position Summary

Title: Quality Assurance Engineer

The Quality Assurance Engineer is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the AAA Indianapolis radioligand manufacturing site.

Major Accountabilities:

• Quality and Compliance aspects of design working in collaboration with Engineering, technical functions, Manufacturing Operations, Quality Control and outside consultants and contractors to ensure that new facility is:

  1. Compliant with all appropriate Client's QMS and regulations (e.g. FDA, EMEA and other major health authorities) for GMP manufacturing.
  2. Capable of manufacturing products that are safe, effective and that meet all applied controls and specifications.
  3. Capable of meeting intended design goals of output volume, turnaround time and operating and product costs.

• Acts as QA point of contact for Quality Control for activities including; release of raw materials, investigation review/approval, protocol approval, review/approval of method validation, etc.
• Provide strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes), CPPs (Critical Process Parameters), Finished Product testing and Microbiological programs.
• Contribute to the definition of project plan, control requirements and processes to deliver the new manufacturing facility on time, to required quality and compliance standards and within budget.
• Contribute to design of facility, utilities and process equipment from a Quality and Compliance perspective.
• Work with validation colleagues to define the initial asset life-cycle model and qualification and validation strategy, to ensure successful validation of the facility. Play a lead role in the planning, execution and closure of commissioning, qualification and validation activities from a Quality functional perspective.
• Collaborate with MS&T to ensure products are maintained in a validated stated.
• Author and/or approve Standard Operating Procedures in support of project activity and deliverables.
• Acts as the Quality approver of change controls, deviations, and CAPAs required to maintain the manufacturing and testing facility in a GMP state.
• Works with supplier and Vendor Management colleagues to ensure that suppliers of goods and services for the new manufacturing facility are compliant and capable of fulfilling their contracted requirements.
• Perform QA approval of major and critical investigations.
• Lead and support internal self-inspections.
• Other related duties as assigned.

Competencies:

  • Continuous Learning (Dyn. Knowledge Development)
  • Digital & Technology Savvy
  • Operational Excellence
  • Being Resilient
  • Breakthrough Analysis
  • Interpersonal Savvy
  • Organizational Savvy
Qualifications:

Education: B.S. degree, preferably in chemistry or biochemistry.

Experiences:

  • 5+ years of experience in a GxP pharmaceutical manufacturing operations.
  • 2+ years of experience in a quality assurance role.
  • Strong knowledge and experience with the application of CFRs and cGMPs and have been involved in regulatory inspections.
  • Strong knowledge and experience of Quality Control testing and methodologies.
  • Experience with comprehensive audit support of all internal and external audits in support of the product manufacture and launch.
  • Experience with radiopharmaceuticals is a plus.
  • Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
  • Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
  • Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Experience participating in internal audits, identify findings, driving to resolution and providing closure report is desired.
  • Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward.
  • Overseeing manufacturing and testing operations as a quality representative.
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