Pharmaceutical Quality Specialist Position Available In Rensselaer, New York
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Job Description
Pharmaceutical Quality Specialist Job Employer Name:
Prowess IT Solutions LLC
SpiderID:
13918955
Location:
Troy, New York
Date Posted:
1/3/2025
Wage:
$150000 per annum
Category:
Healthcare
Job Code:
Number Of Openings:
1
Job Description:
Pharmaceutical Quality Specialist is needed to perform the following duties: Coordinate department preparation and initiatives for pharmaceutical inspection readiness.
Author, edit, review, evaluate and maintain department current Good Manufacturing Practices (which are enforced by the FDA), documentation: standard operating procedures, procedural quizzes, work instructions, standard specifications, job aids, FMEA, gap analysis, memos/addendums/amendments, on-the-job training documentation, instructor-led training material, forms/templates/manuals, equipment/system genealogy/lineage documentation, etc. as per pharmaceutical industry standards or FDA standards.
Write and create periodic evaluation reports for systems used in pharmaceutical manufacturing, analytical testing and training/document tracking/retention.
Author pharmaceutical test plans/test cases/matrices/scripts/technical evaluations and IOQ documents to support validation activities of pharmaceutical systems.
Author, edit, review and maintain pharmaceutical system design documentation (such as User Requirement Specifications, Functional Specifications, Software Design Specification, etc.), following GAMP 5 guidance (founded in the UK to deal with evolving FDA expectations for good manufacturing practices in the pharmaceutical industry).
Write and oversee review/approvals for modifications/change controls/revision histories to pharmaceutical manufacturing documents (standard operating procedures, work instructions, job aids, etc.).
Track departmental pharmaceutical quality records (Investigations) and communicate to department and stakeholders
Monitor and publish department pharmaceutical quality metrics. Analyze data, identify trends and improvement opportunities, and implement solutions.
Job Requirements:
Bachelor Degree is required in
Pharmacy or Regulatory Affairs or Pharmaceutical Science or Pharmaceutics Job Criteria:
Start Date:
06/28/2025
Position Type:
Full-Time Permanent
Years of Experience Required:
Education Required:
Bachelors
Overnight Travel:
Vacation Time:
Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave Contact Information:
Contact Name:
Sanjeev Kumar
Company Type:
Company:
Prowess IT Solutions LLC City:
East Brunswick State:
New Jersey Zip:
08840
