Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose Statement:
Ensures appropriate policies and standards are applied and that engineering activities haverobust quality oversight.Responsible for adhering to Validation Plans for Process Equipment, Facility and Utility, Labequipment and Shipping Validation for initial and periodic evaluation.Coordinate validation activities actively, ensure flawless execution of protocols and proceduresSupport on topics related to Qualification during inspections and auditsResponsible to analyze trends, identify and resolve issues that potentially impact validatedstatus of E/F/U systems.Responsibilities:
Adhere to Validation plan and procedure related to E/F/U systems Qualification, Labequipment Qualification and shipping Validation.Adhere to continually evolving GMP regulations and industry practices with particularrelevance to qualification of E/F/U systems, lab equipment and shipping validation andcontribute to the implementation of plans to address any gapsAdhere to appropriate validation master plans and validation execution plans related to E/F/Usystem, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas,Singapore comprising of both API and Biologics manufacturing facilities.Generate and execute protocols for initial and subsequent re-qualification programs related toE/F/U systems, Lab system and Shipping validation.Work with cross functional team in providing Quality oversight in E/F/U and lab equipmentQualification related procedure and ensure compliance to GMP standards and AbbVie policiesand proceduresActively engaged in developing specifications for E/F/U systems and assist in Commissioning(FAT / SAT etc., not limited) of related system as part of the new build-outsCollaborate with other AbbVie sites within the network to ensure a harmonized approach toQualification.Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment &Shipping validation) topics such as deviations, change management, investigations, CAPAidentification and closure and as a Subject Matter Expert, front regulatory audits, whenneeded.Qualifications
Degree or higher in Science or Engineering or Pharmacy discipline with at least 3 years of relevant work experienceWorking experience and knowledge on Commissioning and Qualification of start-ups and brownfield project experience is a plusHands-on experience in establishment and maintenance of Shipping Validation is a plus.Good leadership and communication skillsExcellent team player willing to work for the common goalKnowledge of pharmaceutical regulatory requirements (GMP) is essentialMust become familiar quickly with products and processes in order to assess quality issues.Shows a high level of tenacity to ensure closure of issues.Largely self-managed with ability to communicate upwards and cross functionally to ensure all key project milestones are met
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html