Lupin Pharmaceuticals (Company Headquarters)

Quality Assurance Validation Engineer

3 months ago
ID
2017-2057
# of Openings
1
Category
Quality Assurance

Overview

The Validation Scientist/Engineer is responsible for carrying out validation activities as they relate to manufacturing and packaging processes, process hold times, cleaning processes, and facilities/utilities/equipment within the Lupin Somerset site. This position assures that all validation activities are executed with the highest quality and meet all applicable SOP’s and regulatory standards. This position will also be responsible for leading Validation projects.

Responsibilities

  • Write or review validation/qualification protocols and respective reports
  • Lead Validation projects, as appropriate
  • Maintain validation packages in support of commercial product in compliance with current regulations/standards
  • Execute Validation/Qualification plans to support product launches, process improvements, and continued commercial production
  • Oversee and perform as necessary: in-process checks, in-process and finished product sampling, and sample submission to the QC lab for testing; follow-up with lab to collect the results, evaluate the data, and write final reports
  • Assist QA in investigations and deviations to determine root cause and to implement appropriate CAPA
  • Initiate any applicable change controls with respect to validation activities, track and follow-up with the required departments to close the change control
  • Write or review IQ/OQ/PQ protocols of process equipment and facility modifications and suggest any required changes. Write or review the reports and ensure that qualifications are performed properly
  • Oversee or sample the air from process rooms on quarterly basis and send to outside Microlab for testing. Receive, review, and analyze the results for any trends
  • Create any new SOP’s and revise the existing SOP’s applicable to validation; train department personnel
  • Evaluate product performance for APRs

Qualifications

  • BS/MA inEngineering discipline or Life Sciences
  • 5+ years experience in FDA-regulated industry
  • 3+ years experience in equipment qualification
  • Excellent knowledge of cGMP in the pharmaceutical/biotechnology industry
  • Excellent computer skills
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required

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