Responsibilities:
- Lead and support all day-to-day qualification activities related to utility, facility and controlled temperature unit (CTU) / shipping validation for the Singapore facilities for Drug Product and Drug Substance, in accordance with approved Validation SOPs / Plan / Policies. Be responsible for validation status maintenance after release.
- Act as key focal point for quality system topics related to respective area of qualification for example deviations investigation, change management, CAPA identification etc. Support to analyze trends, identify and resolve issues that potentially impact validated status of the systems.
- Act as a Subject Matter Expert for Qualification and Validation (related to utility, facility and controlled temperature unit (CTU) / shipping validation) and front customer / regulatory audits.
- Develop and execute validation protocols and reports for initial and subsequent re-qualification, including supporting site discrepancies and deviations investigation / closure.
- Adhere to continually evolving GMP regulations and industry practices with particular relevance to qualification of utility, facility and controlled temperature unit (CTU) / shipping validation and contribute to the implementation of plans to address any gaps
- Collaborate with vendors and other functions to perform system review and technical evaluation of the new equipment or modification, to develop validation testing that will demonstrate that the equipment or modification meet the user or project requirements, good engineering practice, validation requirements and regulatory standards.
- Accountable for the timely and compliant completion of all qualification related activities and milestones
- Plan, manage and coordinate qualification activities with internal and external resources/stakeholders
- Track the qualification deliverables and ensure adherence to schedule for client projects
- Identify and implement improvements where feasible to the qualification processes.
- Provide on the floor support for troubleshooting qualification related issues.
- Will be flexible to take on additional tasks and responsibilities (other areas of validation) at the discretion of the Validation Lead.
Qualifications:
. Bachelor's degree or above in Engineering or Science discipline.
. Demonstrated working experience in utility, facility and controlled temperature unit (CTU) /shipping validation or related validation experience in cGMP environment (5years as a guide)
. Demonstrated hands-on experience in execution of utility, facility and controlled temperature unit (CTU) / shipping validation is essential. Experience in other area of validation (for example sterilization, computerized system etc) is a plus.
. Knowledge of pharmaceutical manufacturing processes in drug substance and / or drug product is essential.
. In depth knowledge and experience of regulatory requirements and industry standards (eg. FDA, EMA, PIC/S, ICHQ7 etc.)
. Excellent verbal and written communication skills in English.
. Able to work independently with limited supervision in a fast-paced environment as well as collaborate with others in a team to work for the common goal.
. Be careful, conscientious and meticulous in duties or work.
. Able to thrive in high-pressure environments, handle multiple priorities and completing tasks accurately within tight deadlines.
. Able to provide on-call support for urgent validation requests occasionally.
. Display a good working attitude, strong work ethic, and willingness to follow leadership directives.
. Strong collaboration, self-motivation, communication, problem-solving and technical writing skills.
. Demonstrated knowledge of pharmaceutical technology and processes
This is a high-growth opportunity for a motivated individual in a fast-paced company. A performance-oriented promotion system, diverse and comprehensive challenges in a cGMP manufacturing environment, and career advancement incentives will all contribute to your career development.
