Post Date: 04 Dec 09
The Challenge:
- Maintain and continually improve all Quality Management systems
- Oversee adherence to ISO, GSDP and GMP standards and prepare for regulatory audits
- Manages the quality assurance team to the highest levels of performance
- Responsible for working with the local regulatory affairs departments
- Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals.
- Supports product variations, including labeling changes, supplements, and amendments; Product License Renewals and providing regional affiliates with timely responses to Health Authority enquiries; as well as regulatory support to all affiliates in the region for the pharmaceutical sector business
- Manage proper standard export packaging components for product registration
- Ensure adequate preparation for health authority meetings, and will need to attend and provide presentations to health authorities, where necessary
What you should possess:
- Degree in Pharmacy or Science
- Minimum 3 years of relevant pharmaceutical industry experience
- A good working knowledge of legal and regulatory issues in the area of Pharma, implementation of quality systems and framework such as GMP, GSDP, IS
- Excellent communication and interpersonal skill
- Excellent verbal and written communication skills
- Only Singaporeans or Singapore PRs may apply
Qualified or interested candidates, please send your updated resume in WORDS FORMAT to Ms Cheryl Zhang at cherylzhang@recruitexpress.com.sg.
0 komentar:
Posting Komentar