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Skills:

Assurance, Compliance, GMP

Job type:

Full-time

• Local batch release includes coordination of Vaccine release by the Health Authority.
• 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 (where applicable as per the country distribution model).
• Where applicable, ensure adherence to AP regional QMS and provide feedback to AP In-market Quality topic owners.
• Ensure Quality perspective is brought into local business initiatives with Quality impact.
• Support local coordination and execution of recalls.
• Support commutation with our Manufacturing Division Quality.
• Support communication with HA issues pertaining to Quality and Supply issues.
• Reports to the In-market Quality lead for Thailand for general advice and instruction concerning Quality Operations.
• Receives guidance, management, and direction and when necessary; executes responsibilities under manager s oversight.
• Keeps manager informed on the status of operations and when challenges, opportunities and/or issues arise.
• Must be Locally registered pharmacist with a valid registered pharmacist license.
• Must have expertise and experience in Quality area (GMP and/or GDP), and nice to have in Supply Chain or Regulatory Affairs.
• Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies.
• Must have interpersonal and communication skills in dealing with complex matter.
• 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.
• Regular
• No relocation
• Hybrid
• 01/17/2025A 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:R330128.

Skills:

Negotiation, English

Job type:

Full-time

• Ensure the product, label, and advertising complied with the regulation, company guidelines, and policies.
• Risk prevention on formulation and label screening.
• Support all necessary regulatory information to related function.
• Maintaining and secure the regulatory database.
• Keep update new regulation.
• Build up a relationship to run the business smoothly with the Food and Drug Administration (FDA), Thai Industrial Standards Institute (TISI), Ministry of Commerce, Office of Consumer Protection Board, Thai Customs, and Others.
• Support all RA projects.
• Bachelor degree up in Food Science, Pharmacy or related field.
• Minimum 10 years working experience in regulatory affairs area especially in food product.
• Strong interpersonal, negotiation, communication and presentation skills.
• Good command of written & spoken English including computer literacy.
• High ability to learn with good attitude.
• Ability to effectively manage projects and good human relation.
• CP AXTRA | Lotus's
• CP AXTRA Public Company Limited.
• Nawamin Office: Buengkum, Bangkok 10230, Thailand.
• By applying for this position, you consent to the collection, use and disclosure of your personal data to us, our recruitment firms and all relevant third parties for the purpose of processing your application for this job position (or any other suitable positions within Lotus's and its subsidiaries, if any). You understand and acknowledge that your personal data will be processed in accordance with the law and our policy. .