Overview
Quality Specialist GMP Manufacturing & Compliance Jobs in Lansdale, Pennsylvania, USA at Freyr Solutions, Client: Global Pharma company
Freyr is hiring for a leading pharmaceutical client!!
Job Title:
Quality Specialist
Location:
West Point, PA 19486
Duration:
Long term contract
Qualifications:
Required
Education:
Bachelor’s degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
Required
Experience and Skills:
Minimum 1-2 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
Familiarity with GMP documentation review
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area..
Responsibilities:
The Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Batch Record Review Quality Manager, the Quality Specialist ensures quality, and compliance of products manufactured by the functional area and adherence to Good Manufacturing and Documentation Practices.
Primary
Activities:
Fully trained in relevant Standard Operating Procedures (SOPs), Work Instructions (WIs) and competency-based activities
Learns cGMPs, the manufacturing process, and our company quality systems, including SAP, GLIMS and electronic logbook, laboratory data, and batch record platforms
Provides presence on the shop floor to support compliance and data integrity.
Reviews production documentation such as batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors
Reviews and approves new and updated SOPs and Controlled Job Aids
Actively participates in the Tier process and uses this forum to make concerns visible and to partner with the functional area on resolution
Fosters a customer service attitude within the functional area
For more details and prompt consideration, please share your resume and we can schedule a call to discuss further.
Regards,
Praveen B
Team Lead, Staffing Dept
Phone:
prav
Title: Quality Specialist GMP Manufacturing & Compliance
Company: Freyr Solutions, Client: Global Pharma company
Location: Lansdale, Pennsylvania, USA
Category: Quality Assurance – QA/QC (Data Analyst), Manufacturing / Production
