RA/QA/PV Pharmacist (8 months contract)

<Job Responsibilities>
• *This position supports and execute the below tasks during the current staff takes maternity leaves.
• *The contract time will be Nov 2022 - May 2023

1. Regulatory Affairs
• Keeping up to date with Thailand national legislations and regulations impacting the registration, marketing, promotion and distribution of pharmaceutical products
• Communicating and updating Regional RA on any new regulatory requirements in Thailand
• Communicating and collaborating with Regional RA and business partners on regulatory issues, including highlighting of potential regulatory problems or supply chain disruptions
• Conducting regulatory assessment and developing regulatory submission strategies for new and current products in Thailand
• Submitting necessary applications to Thailand FDA
• Interacting and maintaining good professional relationship with Thailand FDA officers
• Performing local adaption of regulatory dossiers into eCTD/ACTD format as required by Thailand FDA
• Translating and reviewing texts/artworks required for labelling and ensuring that local labelling requirements are met
• Obtain and/or maintain the necessary regulatory licenses, i.e. Modern Drug Importation and Wholesaling License, Product importation license, etc. as the Responsible Pharmacist/Managing Pharmacist of company in Thailand
• Maintaining a high standard for the archival and retention of regulatory documents
• Read, be aware and follow all RA SOPs and work instructions as applicable

2. Pharmacovigilance
• Establish a PV system in company in compliance with Thailand national legislations, Regional’s PV and International PV requirements, as appropriate
• Conduct employee PV training, i.e., reporting of individual case safety reports for company’s products
• Communicating and updating Regional PV and affiliates on any new PV requirements in Thailand
• Interacting with internal and external stakeholders (i.e., distributors /manufacturers) on PV matters

3. Quality Assurance
• Communicating with regional and business partners on quality issues pertaining to Good Distribution Practices and Good Manufacturing Practices
• QA Liaison with applicable manufacturing/packaging sites
• Conducting batch release / providing quality disposition for the distribution of products
• Participating in regional quality assurance activities, i.e., shipping validation, as required
• Assisting with importation custom clearance activities as the responsible pharmacist for company

4. Others
• Report and communicate about the above issues with Japanese Headquarter or Singapore Regional Headquarter in English
• Other tasks assigned

<Necessary Skills / Experiences>
- Thai nationality, Male, Female, 22-45 years old
- Bachelor’s Degree of Pharmacy
- Fresh graduate welcomed
- At least 1 year experience in RA or QA or PV in medical company
- Conversational high level of English

<Preferable Skills / Experiences>
- Experience in communicating with government
- Having Pharmacist License

Languages skills
English: Conversational Level
Japanese: None

Workplace Area: BTS Ploenchit, Bangkok
Working Hour: 8:00-17:00 (Mon-Fri (Sat: none))

About the Benefits
Salary: 25,000–40,000THB

About the company
Product & Service: Psychiatric products
Business Type: Pharmaceuticals

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