Lowongan Kerja Jakarta Raya Posisi Technical Specialist di PT Talentvis Consulting Indonesia

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Perusahaan	PT Talentvis Consulting Indonesia
Posisi	Technical Specialist
Tempat	Jakarta Raya
Tingkatan Kerja	Supervisor/Koordinator
Kualifikasi	Sarjana (S1)
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Digital Marketing, Penjualan / Pemasaran
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

A great new opportunity as a Technical Specialist for a multinational FMCG company in Jakarta has just become available!

As the Technical Specialist, this role will be responsible for ensuring all relevant regulatory compliances as applicable in Indonesia for the wholesaling of products.

The person will primarily assist the Regulatory Affairs Manager in managing regulatory affairs matters related to company products imported and marketed in Indonesia, including product notification and registration with the respective health authorities, as well as halal certification application management with the Indonesia halal authority.

Responsibilities:

As Technical Specialist, you will work under the supervision and direction of the Regulatory Affairs Manager.

1. You will be the on-the-ground contact person for collaborating with different regulatory bodies, particularly those involved in Post-Market Surveillance
2. Assist the South ASEAN Regulatory Team in responding to health authorities’ inquiries and difficulties.
3. Collaborate with regulatory advisors to create administrative documentation for the product applications.
4. Attend frequent training on product business standards, as required under applicable legislation.
5. Assist South ASEAN Regulatory Affairs Team in maintaining the Product Information File (PIF), technical information, and other Regulatory papers in soft copy and at the CPI office in line with the terms of the applicable regulations.
6. Stay up to date on administrative product Requirements
7. As needed, submit adverse event and distribution records to health authorities every six months.
8. Submit product registration applications as required.
9. Assist the Quality and Logistics units in implementing the approved quality management system in line with business requirements.
10. Ensure that the regulatory information necessary for product purchase is valid and full.
11. Check the accuracy and completeness of distribution and destruction/disposal papers as needed.
12. Assist Quality, Logistics, and other internal functions with product recall actions and communicate recall status with authorities as needed.
13. Monitor and follow-up to verify that the appropriate department addresses and closes consumer concerns.
14. As needed, assist in the qualification and approval of suppliers and consumers.
15. If necessary, assist in the development of an agreement between the contract provider and the contract recipient relating to the distribution of products.
16. Participate in decisions to quarantine or destroy returned, damaged, recalled, or suspected counterfeit products as needed.
17. When necessary, perform self-inspections and ensure that relevant corrective and preventative actions are done.
18. As directed by the Regulatory Affairs Manager, assist South ASEAN Regulatory and Indonesian Team with additional ID regulatory and halal administrative problems.
19. Examine the artwork on product labels and promotional materials, including Bahasa translations.
20. Collaborate with relevant government agencies as needed to support daily operations.

An excellent candidate will need to have a Good Distribution Practice for Medical Device (GDPMD) training certificate or a recognized Halal Supervisor certificate.

Requirements

• A Bachelor’s degree in Pharmacy or similar relevant majors.
• Must have a valid pharmacist Registration Certificate/ Surat Tanda Registrasi Apoteker (STRA) OR a Pharmaceutical Technical Personnel Registration Certificate / Surat Tanda Registrasi Tenaga Teknis Kefarmasian (STRTTK)

Occupational Competencies

• Effective verbal and written communication in English is required.
• Someone who can successfully and constructively collaborate with regulatory partners as well as other functions.
• Capable of demonstrating appropriate understanding of Technical Specialist jobs in Indonesia. 
• Able to successfully monitor regulatory developments pertaining to his/her activities as a Technical Specialist and report to immediate management in a timely way.
• Capable of monitoring project progress, modifying plans, and initiating corrective measures in response to team input and adjustments.
• Extensive experience keeping correct, up-to-date records needed of the Technical Specialist, as well as regulatory actions such as submissions, renewals, and authority contacts/demands.

If you think you meet the requirements and you are driven, determined, and want to be part of a team establishing best practices and policies, this is the role for you!

Apply today to this new opportunity!

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Deskripsi Perusahaan

Info Perusahaan

• Industri: Manajemen/Konsulting HR
• Ukuran Perusahaan: 1- 50 pekerja
• Waktu Proses Lamaran: 28 hari
• Lokasi: International Financial Center, Sudirman