PT Darya-Varia Laboratoria Tbk

DISNAKERJA.COM – PT Darya-Varia Laboratoria Tbk (“Darya-Varia atau Perseroan”) adalah perusahaan farmasi yang telah lama berdiri di Indonesia, beroperasi sejak tahun 1976. Setelah menjadi perusahaan terbuka pada tahun 1994, Perseroan mengakuisisi PT Pradja Pharin (Prafa) di tahun 1995, dan terus mengembangkan berbagai produk Obat Resep dan Consumer Health. Pada Juli 2014, Darya-Varia bergabung (merger) dengan Prafa. Darya-Varia mengoperasikan dua fasilitas manufaktur kelas dunia di Gunung Putri dan Citeureup, Bogor, keduanya memiliki sertifikat Cara Pembuatan Obat yang Baik (CPOB) ASEAN. Kedua pabrik tersebut fokus memproduksi produk-produk Perseroan serta memberikan jasa toll manufacturing untuk pelaku nasional dan multinasional baik untuk pasar lokal maupun ekspor.

Pabrik Darya-Varia di Gunung Putri, Bogor, memiliki spesialisasi dalam produksi kapsul gelatin lunak dan produk-produk cair, sementara Pabrik Darya-Varia di Citeureup, Bogor, memiliki spesialisasi dalam produksi injeksi steril dan produk padat. Perseroan juga melakukan toll manufacturing dengan perusahaan afiliasinya​. Pada 2013, Perseroan memperoleh sertifikat halal untuk kapsul NATUR-E dan HOBAT, produk gelatin yang mengandung unsur hewani, merupakan sertifikasi halal produk suplemen yang pertama untuk perusahaan farmasi di Indonesia.

Lowongan Kerja PT Darya-Varia Laboratoria Tbk

1. QA PHARMACIST

• Conduct Supplier and Material Qualification, Supplier Audit (manufacturer, distributor, transporter, and trader), and Supplier Evaluation and ensure all supplier and material meet the requirement.
• Create, review, and ensure Quality Agreement for all vendor (API, Excipient, and Packaging Material) are available.
• Support Quality Assessment to conduct especially for raw material vendor audit.

2. VALIDATION PHARMACIST

• Prepare protocol, report, and carry-out equipment qualification, building qualification, process validation, cleaning validation, computer system validation, media fill validation/verification, mapping temperature, and periodic review.
• Coordinate with other parties to conduct equipment qualification, building qualification, process validation, cleaning validation, computer system validation, media fill validation/verification, mapping temperature, and periodic review.
• Responsible for validation/verification analytical method and validation media fill execution.
• Responsible or equipment used and maintenance during qualification and validation execution.

3. PQR PHARMACIST

• Prepare and compile Periodic Product Quality Review documents.
• Provide recommendations related to the results of product quality studies.

4. REGISTRATION PHARMACIST

• Prepare, create, and complete QA documents related to registration dossier to support the needs of the HRA Department in terms of product registration to regulatory.
• Review product master batch record and documents related to registration dossier.
• Make a schedule and tracking Registration dossier which is submitted to the HRA Department.
• Maintain master list related to the information contained in the regulatory approval registration.
• Review support in development of new product development and alternate source development.

5. MTU PHARMACIST

• Review of literature study, formula, risk assessment, raw material, also packaging material that will use in Alternate Source Development.
• Coordination with related department on pilot batch and commercial batch for Alternate Source Development.
• Manage the documentation of every stage of the alternate source development in accordance with the regulation of GMP and SOPs.
• Create summary progress report of projects to MTU Supervisor and Manager also solve the problems encountered in the project implementation.

Requirements :

• Apothecary profession, fresh graduates are welcome to apply
• Good verbal and written communication, proficient in English
• Having strong analytical capabilities and be able to act decisively to solve the problems
• Having good knowledge of documentation system, cGMP, quality system, and pharmaceutical regulation
• Good leadership and coordinating cross-function
• Demonstrates an ability to think proactively to ensure that priorities are addressed, and objectives are met

INFO LOWONGAN LAINNYA, DAPAT DITEMUKAN DI: T.ME/DISNAKERJA