The Opportunity
- Adecco is partnering with a reputable pharmaceutical MNC company to search for a Quality Systems Specialist
- Focus: Lead regulatory activities and Coordination on various Pharma programs/projects
- Office location: West, Mapletree Business City
- Working hours: (Monday – Friday) Office Hours
- This role will start off a contract position
The Talent
- Preferably min 6 -7 years of experience in closely related role under pharmaceutical or healthcare industries
- Good Understanding on healthcare and pharmacology terminology.
- Computer literacy with knowledge of MS Office applications.
- Ability to understand and collaborate within and across cross-functional teams and business units, in a fast paced environment.
The Job
This position will serve as main regulatory liaison with internal stakeholders (i.e. global Reg CMC) and/or external parties (i.e. clients / health authorities) for all regulatory activities within site, including registering and filing variations of intended products.
Inspection Management:
· Lead the management of site inspection related activities, such as, but not limited to, inspection readiness activities, internal audit programs (Compliance Walkdowns / Self-Inspections / Corporate Audits) and/or (3) external inspections (Clients / Health Authorities).
· Post inspection responses / actions and follow up with action owner(s) to ensure such responses / actions meets requirements and committed timelines.
Quality Systems and Regulatory activities:
• Lead for the site establishment, maintenance and continuous improvement of designated quality systems and related procedures, and ensure that the systems comply with the policies, standards & procedures, and international regulatory and legislative requirements, as required.
• Lead the management of site systems/ procedures related to regulatory activities, and maintenance of site regulatory relevant licenses and permits as required, including supporting site in setting standards with regulatory relevant information included in both local and international regulatory / legislative requirements, as required.
Continuous Improvements
• Participate/Complete performance appraisal, development and training. Self-develop and support teammates in building a high-performance team with competency/proficiency.
• Other asks assigned by the manager
Next Step
- We could contact you in the soonest time if you directly send your resume to: [email protected]
- Email Topic: Apply: Quality Systems Specialist
- We regret to inform that only shortlisted candidates will be contacted
Ling Kai Hoe
EA Licence Number: 91C2918
Personnel Registration Number: R22106166
