25 km

AbbVie Deutschland GmbH & Co. KG


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Senior TPM PQA Analyst (all genders)
Ludwigshafen am Rhein
Aktualität: 23.06.2022


23.06.2022, AbbVie Deutschland GmbH & Co. KG
Ludwigshafen am Rhein
Senior TPM PQA Analyst (all genders)
To support our diverse team. 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. 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
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




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