Overview

EXTERNAL QUALITY ASSURANCE – PRODUCT QUALITY MANAGER – Specialist Job at Merck in Tipperary

Job Description

Job Description

The Product Quality Manager is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements. Role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release of (API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals) by means of risk-based quality oversight and on-site supervision, as appropriate.

What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:

Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records

Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer

Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented

Conduct routine analytical change requests and support process modification change controls

Stability Program management, including review of stability reports, and Annual Product Review assembly

Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements

Track and monitor operational and quality performance of the external manufacturer/partner

Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine

Support routine process validation; review and approve validation reports/tech transfer

Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes

Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums

What skills you will need:
In order to excel in this role, you will more than likely have:

Solves range of straight forward problems

Receives moderate level of guidance and direction

Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals

Responds to non-standard requests from clients and/or customers; investigations with assistance from others as needed

Explains information and persuades others in straightforward situations

Accountable for technical contribution to project team or sub-team; may manage/lead a small project team

Ability to work across boundaries; developing interpersonal, relationship building and leadership skills

Communicates easily in English both verbally and in writing

Knowledge of External Manufacturing management, supply chain, and operations

Lean Six Sigma Systems training an advantage

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at [email protected]

About Company

Company: Merck

Company Location:  Tipperary

About Merck