Sr. Specialist, Quality Assurance
3주전에
Mandatory: Korean Pharmacist License is required.
The following core responsibilities are generally applicable to the Quality Responsible Person (QRP) role in the countries (Korea):
As registered pharmacist on import, ensure regulations pertaining to Quality and Compliance for importation, quality control, and distribution of the products on the markets (e.g. Good Importation Practice) are fulfilled (where applicable as per the country distribution model) with the following responsibilities:
To approve product release, batch disposition, change control, and local SOPs, .
To check whether product control is carried out in accordance with written procedures.
To supervise product recall
To plan and carry out the self-inspection
To designate a person in charge of storage of materials and products.
As Sr. QA Specialist,
Evaluate products to the market with the assurance that the goods were produced and imported in conformance to all applicable policies/procedures of the compliance with all governing regulations.
Manage routine deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall in Korea
Provide support for audits of partner by and regulatory agencies; review audit outcomes and ensure appropriate and timely corrective actions are warranted
Assess the impact and implement routine analytical change per the planned local filing update or internal update
Conduct Importer’s Annual Product Review including confirming the stability program for imported products
Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
Track and monitor operational and quality performance of the partner
Support Product license renewal with quality documents required per the regulation.
Support in Regulatory advocacy activity as quality representative
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Functional Knowledge:
Must have expertise and broad experience in Quality Systems in Pharmaceutical industry.
Some knowledge of Importer Quality management, supply chain, and operations
Skills:
Solves range of straight forward problems
Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group. contributes and adds value to the achievement of team goals.
Ability to work across boundaries, developing interpersonal, relationship building and leadership skills.
Communicates easily in English both verbally and in writing.
Receives moderate level of guidance and direction.
Leadership Behaviors:
Planning to Experimentation - Make effective and rapid decisions for the business based on incomplete information or without being certain of the outcomes. Experience with courageous new ideas, approaches and improvements to current processes. Accountable for extracting lessons learned from failures and mistakes.
Silos to Networks - Build partnerships, break down barriers, and collaborate across the enterprise in a positive way. Engage and align multiple internal and external stakeholders towards a common goal.
Build a Diverse and Inclusive Culture - Attract, retain and develop employees of different cultures, backgrounds and experience, actively contribute to creating a culture of inclusion; foster an environment in which each person feels empowerment to contribute their unique perspective.
Focus on Customers, Including Patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs.
Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.
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: Temporary (Fixed Term)
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:10/25/2024
*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.
R313468
-
Seoul, 대한민국 MSD 풀타임Mandatory: Korean Pharmacist License is required.The following core responsibilities are generally applicable to the Quality Responsible Person (QRP) role in the countries (Korea):As registered pharmacist on import, ensure regulations pertaining to Quality and Compliance for importation, quality control, and distribution of the products on the markets (e.g....
-
Quality Assurance Specialist
6 개월전에
Seoul, 대한민국 Work Visa USA Jobs (move2usajobs.com LLC) 풀타임Job DescriptionAn outstanding opportunity is available for Quality Assurance Specialists looking to bring their expertise and precision to the United States. This role is crafted for professionals dedicated to ensuring product and service excellence, enhancing customer satisfaction, and contributing to the continuous improvement of processes within a vibrant...
-
Quality Assurance Specialist
6 개월전에
Seoul, 대한민국 Work Visa USA Jobs (move2usajobs.com LLC) 풀타임An outstanding opportunity is available for Quality Assurance Specialists looking to bring their expertise and precision to the United States. This role is crafted for professionals dedicated to ensuring product and service excellence, enhancing customer satisfaction, and contributing to the continuous improvement of processes within a vibrant market. Ideal...
-
Sr QA Specialist, APAC
4 개월전에
Seoul, 대한민국 Boston Scientific 풀타임Additional Locations: N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Quality Assurance Manager
2 개월전에
Seoul, 대한민국 Takeda 풀타임Description Job Title: Quality Assurance Manager Location: Seoul, Korea About the role: The role's purpose is to drive quality compliance to meet Health Authority and Takeda requirements are met, safeguarding PTRB (Patient, Trust, Reputation and Business) and aligning with the Local Operating Company (LOC) Korea business strategy. The...
-
Seoul, 대한민국 J&J Family of Companies 풀타임[MedTech] Sr. Communications Specialist W DescriptionAbout Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in in...
-
Sr. PV specialist
4주전에
Seoul, 대한민국 J&J Family of Companies 풀타임[Janssen] Sr. PV specialist W DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and...
-
Sr. RA Specialist
4주전에
Seoul, 대한민국 J&J Family of Companies 풀타임[Janssen] Sr. RA Specialist W DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and...
-
Sr. RA Specialist
3주전에
Seoul, 대한민국 J&J Family of Companies 풀타임[Janssen] Sr. RA Specialist W DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and...
-
Quality Specialist
1개월전에
Seoul, 대한민국 Thermo Fisher Scientific 풀타임: Develop and maintain Quality Management System in South Korea by promoting Quality Mindset within the organization. Maintain the Quality Management System in compliance with regulatory (including Korea Medical Device Act) and internal requirements. Ensure compliance with current regulations and standards and obtaining and maintenance of ISO 13485...
-
Sr. RA Specialist
4주전에
Seoul, 대한민국 J&J Family of Companies 풀타임[Janssen] Sr. RA Specialist W DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical, medical devices and...
-
Quality Specialist
1개월전에
Seoul, 대한민국 Thermo Fisher Scientific 풀타임: Develop and maintain Quality Management System in South Korea by promoting Quality Mindset within the organization. Maintain the Quality Management System in compliance with regulatory (including Korea Medical Device Act) and internal requirements. Ensure compliance with current regulations and standards and obtaining and maintenance of ISO 13485...
-
Seoul, 대한민국 J&J Family of Companies 풀타임[Janssen] IPV Case Management Sr. Specialist W DescriptionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in pharmaceutical,...
-
Seoul, 대한민국 Bristol Myers Squibb 풀타임Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Seoul, 대한민국 Bristol Myers Squibb 풀타임Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
[한국화이자제약] Market Access
4 개월전에
Seoul, 대한민국 Pfizer 풀타임ROLE SUMMARY: Sr. Pricing & Reimbursement Specialist (Sr. P&R Specialist) or Pricing & Reimbursement Manager (P&R Manager) is responsible for managing and conducting assigned assets’ pricing & reimbursement for the launch and life-cycle management as well as creating opportunities with long-term market access strategy ROLE RESPONSIBILITIES: Leads...
-
Seoul, 대한민국 Bristol Myers Squibb 풀타임Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Seoul, 대한민국 Omnivision Technologies, Inc. 풀타임About:As a Sr. Field Applications Engineer, you are primarily responsible for proving technical expertise through presentations, product demos, installation and maintenance of company products. You are also required to assist sales staffs in assessing potential application of company products to meet customer needs, prepare detailed product specifications...
-
Seoul, 대한민국 Omnivision Technologies, Inc. 풀타임About: As a Sr. Field Applications Engineer, you are primarily responsible for proving technical expertise through presentations, product demos, installation and maintenance of company products. You are also required to assist sales staffs in assessing potential application of company products to meet customer needs, prepare detailed product...
-
Seoul, 대한민국 OMNIVISION 풀타임Description About: As a Sr. Field Applications Engineer, you are primarily responsible for proving technical expertise through presentations, product demos, installation and maintenance of company products. You are also required to assist sales staffs in assessing potential application of company products to meet customer needs, prepare detailed...
