Lead the EFU team and respective contractors to deliver validation activities per Abbvie Singapore operational needs in accordance to AbbVie quality management system and regulatory requirement.

　　A ct as the Subject Matter Expert (SME) related to E/F/U systems Qualification, Lab equipment Qualification and shipping Validation.

　　Remain abreast of continually evolving GMP regulations and industry practices with particular relevance to qualification of E/F/U systems, lab equipment and shipping validation and contribute to the implementation of plans to address any gaps

　　Establish/ Ensure appropriate validation master plans and validation execution plans related to E/F/U system, Lab equipment and Shipping validation in the AbbVie Operations Campus in Tuas, Singapore comprising of both API and Biologics manufacturing facilities.

　　Generate, review and execute protocols for initial and subsequent re-qualification programs related to E/F/U systems, Lab system and Shipping validation.

　　Work with cross functional team in providing Quality oversight in E/F/U and lab equipment Qualification related procedure and ensure compliance to GMP standards and AbbVie policies and procedures

　　Actively 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-outs

　　Collaborate with other AbbVie sites within the network to ensure a harmonized approach to Qualification.

　　Develop monitoring and control regimes and play a key role in improving compliance KPIs

　　Act as one of the key focal points for Qualification and Validation (E/F/U, Lab equipment & Shipping validation) topics such as change management, investigations, CAPA identification and closure and as a Subject Matter Expert, front regulatory audits, when needed.

　　To actively assist in recruitment, nurturing and retention of employees and contractors to support ongoing and future business needs

　　Education

　　Degree or higher in Science or Engineering or Pharmacy discipline with at least 7 years of relevant work experience.Job/ Technical Skills

　　Working experience and knowledge on Commissioning and Qualification of start-ups and brownfield project experience is a plus

　　Hands-on experience in establishment and maintenance of Shipping Validation is a plus.

　　Business Skills

　　Excellent leadership and communication skills

　　Ability to lead, train and supervise teams in activities related to Commissioning and Qualification including external contractors

　　Mentoring and coaching skills

　　Excellent team player willing to work for the common goa

　　Demonstrates the highest levels of integrity and a strong work ethic at all times

　　Is results driven striving to meet all targets and metrics as set by department/site and company leader

　　Knowledge of pharmaceutical regulatory requirements (GMP) is essential

　　Must 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.

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.