MSD Quality Assurance Sr Specialist 

Indonesia, Special Capital Region of Jakarta 

912942110

Job Description

Position Overview - Basic Functions & Responsibility

The following core responsibilities are generally applicable to the Quality Assurance Specialist (Quality Responsible Person) role in the country:

• Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled
• Ensure adherence to Our Manufacturing Division and provide feedback to Manufacturing Division QMS topic owners.
• Health Authority (HA) interactions and notifications regarding Quality
• Information and interaction with local business and regional Quality Management
• Ensure Quality perspective is brought into local business initiatives with Quality impact
• Local coordination and execution of recalls
• Primary country contact for Manufacturing Division Quality
• Primary country contact for HA issues pertaining to Quality

In addition, the following responsibilities apply as Registered Pharmacist:

• Verify and approve all in-market distribution related documents (eg. Inbound & outbound)
• Maintain validity of in-market licenses e.g. Distribution certificate, GDP certificate, and practice license (SIPA)
• Manage compliance of product distribution report to HA in regular basis (e.g. Monthly/ quarterly distribution report, serialization, etc.)
• Manage planned & ad-hoc HA inspection and Internal Audit

Authority

The responsibilities above also include authority to issue instructions, act and take decisions to fulfill HA requirements and to safeguard patient health.

In case of serious product quality related issues (e.g. serious complaints, deviations impacting quality or a potential market action) the Quality Assurance has the authority to proceed with necessary actions (e.g. HA notification, administrative hold, recall) as per required urgency and will work in close cooperation with key functions in the Manufacturing Division Quality organization (i.e. Qualified Persons).

Skills required

• Bachelor’s degree inpharmacy with apothecary education program
• Must be Locally registered pharmacist with a valid registered pharmacist license
• Must have expertise and broad experience in Quality area (GMP and/or GDP),familiar with applicable local regulations/ laws/ HA requirements in pharmaceuticals.Nice to have in Supply Chain or Regulatory Affairs
• Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
• Must have excellent management of CAPA, Deviation, Change Control, and quality oversight to external partner.
• Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
• Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams.

Current Contingent Workers apply

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