Overview

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com.  

Want to be part of a high performing team? We offer that
Ready to invest in your career? We offer that too

Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients‘ lives around the world. In short, we know it takes «you» to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that’s felt within healthcare and beyond.

We are now hiring for our site in Ludwigshafen/Rhine a highly motivated

to support our diverse team.
REF: 2206830

The Senior Product Quality Assurance (PQA) Analyst has various objectives / functions related to Third Party Manufacturer (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day-to-day Quality Assurance activities related to the TPM plants including but not limited to review and approval of master batch records, testing specifications, manufacturing investigations including assessment of product impact, effectivity of corrective and preventive actions as well as review and approval of changes.

The Senior PQA Analyst also is responsible to monitor process capabilities and trends and to perform annual Product Quality Reviews. The responsibility is for revision of Quality Technical Agreements, too. This person also acts as a liaison between AbbVie regulatory areas and TPMs for regulatory submission.

Your Job is to:

Maintain an effective liaison and cooperative relationship with other AbbVie areas including but not limited to Quality, Regulatory, Technical, Supply Chain, along with the TPM
Ensure that drug product production at TPMs is performed as per current good manufacturing practices, according to local procedures and as per specifications provided by AbbVie
Ensure TPM procedures are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreements
Provide support to PQA in global compliance projects
Ensure investigations of quality events at TPMs, e.g. process, laboratory, primary packaging materials are completed in a thorough and timely manner, and documented accurately, including adequate product impact analyses and definition of effective corrective and preventive actions
Perform Product Quality Reviews according to AbbVie global procedure to comply with regulatory requirements
Participate in the Trend Review Board to monitor process track and trending
Participate in the Global Change Review Board to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions
Generate change management plans related to TPMs including planning, risk analysis, and implementation

Qualifications:

Master’s degree preferably in pharmaceutical sciences or equivalent field of study or other equivalent education as well
Minimum of six years of experience within pharmaceutical operations, preferably Biologics manufacturing processes
Knowledge of cGMP regulations and standards affecting pharmaceutical products
Comprehensive knowledge and application of business processes and quality management concepts
Strong analytical skills and attention to detail
Experience in management of changes and exceptions
Profound knowledge in Trackwise
Proven ability to adapt the communication style for a variety of modes as well as for multicultural audiences
Strong interpersonal relations and proficient communications skills in German and English 
Ability to effectively communicate, e.g. explain complex content in simplified form, across all levels of the organization

Are you ready now to be part of this innovative diverse team? Apply Now!
We are looking forward to  your application. Please provide information about your salary expectations and possible start date in your motivation letter. 

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce. 

Learn more about AbbVie Deutschland at www.abbvie.de. 

PEOPLE. PASSION. POSSIBILITIES.

AbbVie Deutschland GmbH & Co. KG http://www.abbott-care.de http://www.abbott-care.de https://files.relaxx.center/kcenter-google-postings/kc-10980/logo_google.png

2022-07-19T10:54:41.999Z FULL_TIME
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Ludwigshafen am Rhein 67061 Knollstraße 50