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

Quality Responsible Person/Registered Pharmacist 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 in pharmacy 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 Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular
Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid
Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
12/14/2024

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R320125