Assistant Validation Manager

Job Responsibilities:

·        Plan, coordinate and oversee validation and qualification activities to ensure timely completion in accordance with the Validation Master Plan (VMP), GMP requirements and established schedules.

·        Manage Process Validation (PV), Cleaning Validation (CV), Equipment Qualification (EQ), Facility and Utility Qualification, and Computer System Validation (CSV), including periodic review and requalification where applicable.

·        Development of validation documentations for CSV and EQ. Review Process Validation (PV) and Cleaning Validation (CV) protocol and report.

·        Coordinate validation work with other related department e.g. Production, PPIC (Production Planning & Inventory Control), Engineering, Procurement.

·        Involve in validation documentation focuses on the high-level documentation (VMPs, VPs and related protocols).

·        Ensure the progress and completion of Process Validation (PV), Cleaning Validation (CV), Equipment Qualification (EQ) and Computer System Validation (CSV) verifying the manufacturing or cleaning process, testing, storage & distribution, as well as related reports wherever applicable

·        Support product registration through preparation and submission of validation documents.

·        Ensure that validation and qualification activities are conducted using a risk-based approach and that facilities, equipment, utilities, processes and computerised systems remain in a qualified or validated state.

·        Ensure that all relevant standard operating procedures are revised and updated in accordance to stipulated intervals.

·        To participate actively in self-inspection and audit programs organized by QA Department.

·        Supervise, coach and develop Validation personnel, including work allocation, competency development and performance monitoring.

Job Requirement

·        Bachelor’s degree, preferably with Engineering, Science, or IT-related discipline.

·        Minimum 5 years working experience in this /related field, especially validation.

·        Sound knowledge of GMP requirements, particularly PIC/S GMP Annex 15, and applicable validation and qualification principles.

·        Good understanding of change control, deviation management, risk assessment and validation lifecycle management.

·        Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines.

·        Ability to work with multi-departmental team and personnel at various levels in the facility.

·        Excellent supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs.

·        Strong interpersonal and communication skills: oral/written and listening.

·        Pharmaceutical GMP knowledge.

·        Proficiency in Microsoft Office applications.

·        Behavioral Competencies:

1.      Initiative, Commitment, Personal Leadership, Interpersonal Effectiveness, Productivity.

2.      Consistently operate with the highest standards of ethics and compliance.

3.      Go the extra mile to make things happen. Take action with great speed and efficiency no matter the task.

4.      Embrace change with enthusiasm.