Senior Pharma QA Lead - Manufacturing

Piramal Pharma Limited

Lexington (VA)

On-site

USD 85,000 - 120,000

Full time

14 days+
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Job summary

Piramal Pharma Solutions in Lexington, VA is seeking a Sr. Manufacturing QA Specialist to ensure compliance during manufacturing, testing, warehousing and distribution of pharmaceutical products.

The role reports to the QA Supervisor, with responsibilities across audits, line clearances and QA oversight on the floor. The position requires 3+ years of pharmaceutical QA experience, strong knowledge of cGMP/FDA regulations, and excellent technical writing and communication skills.

Qualifications

  • Bachelor's degree in physical or biological sciences or related field preferred.
  • 3+ years of QA experience in pharmaceutical manufacturing.
  • Thorough knowledge of cGMP and FDA regulations.
  • Proficiency in Word, Excel and data reporting.
  • Strong written and verbal communication skills.

Responsibilities

  • Write, read and revise technical reports.
  • Train and support staff regarding QA responsibilities.
  • Review batch records and protocols and coordinate issue resolution.
  • Summarize site metrics data.
  • Assist QA leadership in process mapping and system analysis.
  • Review logs, calibration, HEPA certs and related documentation.
  • Conduct on-floor QA oversight and product inspections.
  • Participate in audits and self-inspections.
  • Represent QA in client meetings and investigations.
  • Execute training plans and address GMP issues.

Skills

QA
Regulatory compliance
Technical writing
Quality systems
Communication

Education

Bachelor's degree in physical or biological sciences
High school education or equivalent

Tools

Microsoft Office

Job description

Piramal Pharma Solutions in Lexington, VA is seeking a Sr. Manufacturing QA Specialist to ensure compliance during manufacturing, testing, warehousing and distribution of pharmaceutical products.

The role reports to the QA Supervisor, with responsibilities across audits, line clearances and QA oversight on the floor. The position requires 3+ years of pharmaceutical QA experience, strong knowledge of cGMP/FDA regulations, and excellent technical writing and communication skills.

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