- Sole responsibility of organisational structuring of the Validations team within the QRM unit.
- Manage team hierarchical structure and performance of the Validations team.
- Ensure qualifications of personnel in the hierarchical structure of the team.
- Ensure proper training programs to be implemented into the hierarchical structure so that right person for the right job' concept can be assured.
- Oversee validation activities for the OCP, HSP and ESP site.
- Establish standard turn around times(TAT) for activities and ensure management of those TATs.
- Review and approve standard operating procedures for the Validations team (QC/Manufacturing depending on experience).
- Participate in regulatory agency response for the Validations team or train & designate an appropriate qualified responder for the Validations team
- Bachelors degree in a science related field (engineering, biology biochemistry etc). Masters or Ph.D in science related field preferred.
- Minimum of 10 years experience in the pharmaceutical industry in a GMP environment.
- Must have regulatory agency defence experience with a successful tract record.
- Strong command of the English and Korean language in the written form. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition and grammar and have a keen eye for detail.
- Experience with ISO, FDA, EMEA, WHO and PICs guidelines and requirements and a good track record of implementation based on those guidelines and requirements.