QA Specialist - Biologics

at  Morgan McKinley

Cork, County Cork, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate21 Jul, 2024Not Specified29 Apr, 20243 year(s) or aboveGood communication skillsNoNo
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Description:

This role encompasses various responsibilities including Incoming Material Release, Batch Release, Change Control, Event Management, Supplier Qualification, Annual Product Review, and Validation Compliance activities.

Responsibilities:

WHAT YOU WILL DO:

  • Review batch records and release materials to ensure adherence to GMP requirements.
  • Administer event management systems, including reviewing and approving Events, Deviations, and Customer Complaints.
  • Manage batch record design and approval processes.
  • Administer the SAP Quality Management Module.
  • Oversee site change control systems.
  • Compile Annual Product Reviews.
  • Support validation activities outlined in the Site Validation Master Plan.
  • Review and approve validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Support system qualification and process validation activities.
  • Review and approve SOPs, work instructions, and forms from other departments on behalf of Quality Assurance.
  • Coordinate and assist in the preparation for regulatory and customer GMP inspections.
  • Participate in New Product Introduction Teams.
  • Conduct on-site and vendor facility GMP audits as needed.
  • Conduct regular on-the-floor walkdowns to ensure adherence to GMP standards.
  • Administer the site supplier approval process.


REQUIREMENT SUMMARY

Min:3.0Max:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Software Testing, Clinical Pharmacy

Graduate

A scientific/technical discipline

Proficient

1

Cork, County Cork, Ireland