Manufacturing Quality Analytical Manager

Company: Alpha Consulting Corp.
Location: New Brunswick
Posted on: May 28, 2023

Job Description:

MANUFACTURING QUALITY ANALYTICAL MANAGER NEW BRUNSWICK, NJ Project Description: Management of analytical tech transfer activities across API & Drug Product in an external manufacturing environment. Provision of analytical expertise and troubleshooting support in the areas of API's and intermediates, drug products, raw materials, and Pharmacopoeia requirements in an external manufacturing environment. Proactively manage all API & Drug Product Contract Laboratory Service (CLS) providers to Global External Manufacturing from a quality and compliance oversight perspective. Engage with internal and external stakeholders to plan and manage the program for analytical method transfers from Client to CMOs or CMO to CMO. Represent Global External Manufacturing as the QC laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits. Review and approve all major laboratory investigations/OOS events at CMOs & CLS providers. Provide technical support to the QP and Quality Operations Managers in relation to same. Review and approve analytical change control documents associated with CMOs & CLS providers. Facilitate and manage the communication flow to and from CMO analytical functions and global functions across Client such as Global Testing Standards, HQ. Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences etc. Review and approve analytical method validation documentation & activities at CMOs and CLS providers to determine compliance with ICH requirements and manage remediation of gap analysis at Client or CLS. Provide analytical expert support for regulatory submissions. Prepare, approve, and maintain the Quality Agreement with each CLS provider. Establish and monitor an effective metrics program to measure the performance of the CLS providers. Provide training to a wider External Manufacturing team. Required Skills: A minimum of a MBA in Chemistry or related discipline is also required together with a sound understanding of GMP & ICH guidelines. In depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory. API and Drug Product experience. Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills. Project Management skills are required. Strong technical knowledge of modern chromatographic methodologies. Management of Third-Party relationships (desirable). A minimum of 5 years' experience in a QC/QA environment is required for this role. Ability to work independently and within team matrix environments. Thorough knowledge of worldwide regulatory GMP requirements and a working knowledge of FDA & EU GMP requirements. In-depth knowledge of Quality Management Systems relating to laboratory operations. Ability to objectively critique investigation reports from third parties. Good knowledge of API and Drug Product processes and ability to differentiate between requirements. Please E-MAIL your resume (attachment to email) with rate and availability to Trez: trez@alphaconsulting.com ALPHA'S REQUIREMENT #23-00904 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE PDN-99213748-5abe-4f55-9b40-931580272912

Keywords: Alpha Consulting Corp., New Brunswick , Manufacturing Quality Analytical Manager, Executive , New Brunswick, New Jersey