- Pharmaceutical Manufacturing facility cGMP validation experience in all processes and equipment in a sterile environment required.
- Grade A/Class 100 Cleanroom equipment validation experience required.
- Experience in the US, EU and/or Asia is required.
- Direct experience in tech transferring API and drug products from development through PQ/PV and successful hand off to commercial team for launch.
- Ability to formulate and manage VMPs.
- Ability to lead the project without direct supervision.
- Preferred: Risk evaluation and mitigation strategy (REMS) program experience; prior experience managing contract and/or outsourced organizations.
- Ensuring that the product conforms to all Critical Quality Attributes (CQAs) and meets all Critical Process Parameters (CPPs) at all stages of the manufacturing process during tech transfer and validation
- Ensures the drug substance and drug product can be sustainably manufactured through applying Quality by Design (QbD) principles and techniques.
- Works cross-functionally to ensure that there is an appropriate quality handoff and transition through PQ/PV and the commercial business
- Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product
- Manages any third-party activities (including risks)
- Create, revise, review, and approve validation protocols impacting the product.
- Conduct periodic reviews for adequacy of Validation and Tech Transfer policies and procedures to assist the business in the strengthening of the PQS (procedures and working practices) and to meet current and regulatory requirements.
-
Assistant Project Manager
1 week ago
Ruppert Landscape Construction Raleigh, United StatesJob Description · Job DescriptionRuppert is a commercial construction company combined as a privately and employee owned specialty contractor. A multi-state presence with a small company feel, our mission is to provide opportunities for our people, take care of our customers, and ...
-
IT Project Manager-PMP
6 days ago
Novalink Solutions LLC Raleigh, United States***CURRENT PMP Certification is REQUIRED. · The North Carolina Department of Revenue (DOR) is seeking an experienced IT Project Manager contractor for an approximately 6-month engagement for the Project Management Office (PMO). This person will be responsible for managing and coo ...
-
IT project manager
1 week ago
Apex Solutions Garner, United StatesAt CHG-MERIDIAN, we see ourselves as a large international family. Despite our company size of over 1300 employees worldwide, new colleagues feel like part of our dynamic team from the very beginning. · What to expect · In our IT department, we currently employ around 90 employee ...
-
Project Manager
1 week ago
ZephyrTech Garner, United StatesSince 2015, INconnect has been offering its expertise in network expansion and takes care of everything that arises during infrastructure development, from initial planning to final implementation. · We are now represented nationwide at four locations with more than 150 employees ...
-
Project Manager
1 week ago
Skyline Solutions Garner, United StatesBalda at the Bad Oeynhausen location is a specialist for plastic components in the pharmaceutical, diagnostics, and medical technology fields. Since 2016, Balda has been part of the Italian Stevanato Group with over 5,000 employees worldwide. · Passion – Spirit – Enthusiasm · Wit ...
-
Project Manager
1 week ago
Stellar Enterprises Knightdale, United StatesThe hvv is responsible for managing public transportation (ÖPNV) in the metropolitan region of Hamburg, covering three federal states, eight districts, 30 transport companies, and approximately 3.67 million inhabitants. With around 90 employees, hvv GmbH is the coordinating organ ...
-
Project Manager
6 days ago
CQC Home Durham, United States**Careers**: Welcome to CQC A fast-paced, dynamic company on a significant growth trajectory.- Our mission is to tangibly improve the lives of our customers & our employees. · - For our employees, this is evident by the family-like culture that we have built and the many benefits ...
-
Project Manager
3 days ago
Windrose Staffing LLC Raleigh, United StatesPROJECT MANAGER ~ HEAVY CIVIL CONSTRUCTION in NC · Are YOU a Project Manager who enjoys planning, overseeing the building process, and motivating your team to be safety-minded, scheduled, and budget conscience from start to finish? If your heavy civil PM skills range from pre-con ...
-
Project Manager
6 days ago
Rose International Raleigh, United StatesDate Posted: 05/08/2024 · Hiring Organization: Rose International · Position Number: 463718 · Job Title: Project Manager · Job Location: Raleigh, NC, USA, 27615 · Work Model: Hybrid · Employment Type: Temp to Hire · Estimated Duration (In months): 15 · Min Hourly Rate ($) ...
-
Project Manager
1 week ago
Advanced Recruiting Partners Raleigh, United StatesJob Description: · The Project Manager will be responsible for overseeing the installation and management of IT infrastructure throughout the construction of a new manufacturing facility. The ideal candidate will have experience in project management, preferably with a background ...
-
IT Project Manager
1 week ago
Apex Systems Raleigh, United StatesApex's financial client is hiring an experienced, PMP-certified Project Manager that will support mostly app dev/systems project in Agile and Waterfall environments. · Location: 3 days on-site in Raleigh, NC · Duration: 12+ months, potential conversion to FTE · Terms: W2-contrac ...
-
Project Manager
1 week ago
Serigor Inc Raleigh, United StatesJob Title: Project Manager (Remote) · Location: Raleigh, NC · Duration: 12+ Months · Job Description: · The Project Manager will work closely with the DEQ Program Manager, and members of the project team to manage administrative tasks and support key financial, project management ...
-
Project Manager
1 day ago
DataStaff, Inc. Raleigh, United StatesDataStaff, Inc. is currently seeking a Project Manager to fill a long-term contract opportunity with one of our direct clients in Raleigh, NC. · ***This position is remote. However, the contractor will be required to work during the core business hours of 8am – 5pm EST · Respo ...
-
Project Manager
1 week ago
Pivot Workforce, LLC Raleigh, United StatesJob Description: As a Mechanical Project Manager in the construction industry, you will play a critical role in overseeing and coordinating mechanical systems installations and projects. · Qualifications: Bachelor's degree in Mechanical Engineering, Construction Management, or a ...
-
Project Manager
1 week ago
Infinity Technologies White Oak, United StatesWe are looking for a Project Manager (m/f/d) to join our Energy Solutions team at White Oak, responsible for implementing energy solutions for commercial customers with a focus on PV, charging infrastructure, storage, and energy management. · In this role, you will be responsible ...
-
Project Manager
6 days ago
Hughes Engineering, PLLC Raleigh, United StatesHughes Engineering & Consulting is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and Validation solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career and personal lea ...
-
IT Project Manager
6 days ago
Serigor Inc Raleigh, United StatesJob Title: IT Project Manager - Expert (Hybrid) · Location: Raleigh, NC · Duration: 12+ Months · Job Description: · The client is seeking to replace the current Laboratory Information Management System (LIMS) for their Newborn Screening program with a new Newborn Screening Pr ...
-
Project Manager
1 week ago
GTN Technical Staffing and Consulting Raleigh, United StatesWe have a Project Manager role available in our restoration and waterproofing division in Raleigh, NC · As a Project Manager, you will engage in all aspects of the business, from customer relationship development to estimating, contract procurement, schedule and change management ...
-
IT Project Manager
2 weeks ago
ITProFound Raleigh, United StatesJob Title : IT Project Manager - Expert · Duration: 12+ Months · Client : State of NC · Location: NC DHHS Six Forks Rd, Building 2, Raleigh, NC (Hybrid) · Job description: · Short Description: · Client is seeking a senior project manager to manage the planning and implementation ...
-
Project Manager
2 days ago
Pierce Raleigh, United StatesThe ideal candidate for this position will have run projects for cross-functional teams, with a working knowledge of both business and IT project requirements. Projects may span infrastructure, application development, security, and business process. Oftentimes, if not most of th ...
Product Quality Validation Project Manager - Raleigh, United States - SRG
Description
SRG, the leader in the Life Sciences human capital industry, is looking for a full-time Product Quality Validation Project Manager for a global pharmaceutical company located in Raleigh, NC. This role is responsible for oversight of tech transfer and validation activities in a sterile environment as a critical part of the global quality organization. This position requires a candidate with extensive experience managing large facility validation projects and tech transfer products.
What you need to have:
Responsibilities include, but are not limited to:
** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."