Job Description:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.
Comments/Special Instructions
Completion of BCG Medical Surveillance required prior to start of work
Qualifications:
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
...initiatives that advance environmental, energy, economic, and social sustainability. The CSO will provide visionary leadership, oversee... ...sustainability matters. The successful candidate will also be responsible for engaging with the public, community organizations, and...
...The Grants Manager coordinates financial and administrative operations relating to hospital grants, both public and private. Primary areas of responsibility include supporting the work of the AVP and Director, pre- and post-award financial reporting & budgeting, budget...
Stonerise Princeton is currently recruiting for a Part Time LPN, Day Shift. Why Join the Stonerise Family? Leave A Lasting Legacy... ...life, and other voluntary group programs) DailyPay 401 (K) retirement savings plan Tuition reimbursement Advancement...
...We are directly working with the hiring manager and currently seeking a Sr BI Consultant - Power BI for our direct client in Pharmaceutical industry. Duration: Contract (c2c/1099/w2) Location : Raritan, NJ 2-3 days Hybrid 5 years minimum experience as...
* *Position: Physical Therapy Assistant (PTA)- Rehab** *Location: 3401 West Gore Blvd, Lawton, OK 73505** *Duration: Fulltime (Permanent).** *Shift: 8:00A - 5:00P (8 Hour Days)**Salary Range: $24.50 - $27.56/hour (based on experience)**$6,000 SIGN-ON BONUS**...