Lowongan Kerja Jakarta Raya Posisi Laboratory Specialist di PT Pfizer Indonesia

Info Loker

Perusahaan	PT Pfizer Indonesia
Posisi	Laboratory Specialist
Tempat	Jakarta Raya
Tingkatan Kerja	Tidak Terspesifikasi
Kualifikasi	Tidak terspesifikasi
Jenis Pekerjaan	Full Time
Spesialisasi Dibutuhkan	Sains, Sains & Teknologi
Gaji Min	Rp. 1.800.000
Gaji Max	Rp. 5.500.000

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective laboratory compliance team. You will have the all important role of conducting study and analytical method validation to comply with current compendia and Pfizer standard. You will be relied on to make sure that they comply with the policies, procedures and practices laid down by the regulatory agencies. Your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will arrive at decisions on which methods and procedures are the best fit for different work situations. It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Assist Quality Process Improvement Manager and/or Lab Compliance Supervisor for writing or updating Lab’s Standard Operating Procedure (SOP)/ Standard test procedures and other GMP document in accordance with actual practices, PQS, current GMP, and regulatory requirements.

• Prepare protocol and report of analytical method verification/validation for finished product and raw material

• Conduct execution and review the data of analytical method verification/validation

• Support Lab Compliance Supervisor to manage the site compendia compliance project

• Support Lab Compliance Supervisor for CAPA closure

• Maintain QC laboratory documentation and support laboratory investigation, manufacturing investigation, and all related commitments

• Perform training to QC chemical lab personnel

• Maintain Laboratory area, equipment, facilities in a clean, orderly and operational state.

• Monitor that all reagents, reference standard, and testing equipment are always available and ensure all reagents and reference standards are valid to use and stored according to requirement.

Qualifications

Must-Have

• Bachelor’s Degree in chemistry or pharmacist

• 2+ years’ experience. Experienced with analytical method development and validation/verification of drug product and raw material will be plus

• Certification in assigned area, if applicable

• Successful hands-on analytical testing experience in a Good Manufacturing Practices {also cGMP} environment

• Technical Skills- Knowledge of laboratory equipment, testing and technique

• Familiar with compendial requirement

• Good knowledge and application of data integrity

• Knowledge of regulatory compliance requirements for pharmaceutical manufacturing

• Strong organizational skills and ability to multi-task across projects and activities

• Good analytical thinking and high-level integrity

• Able to work well either as an individual or as a team member

• Excellent interpersonal and communication skills

Nice-to-Have

• Good knowledge of regulatory dossier requirement and registration process

  
 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control#LI-PFE-

Lamar kerja

Deskripsi Perusahaan

Info Perusahaan

• Industri: BioTeknologi/Farmasi/Riset klinik
• Ukuran Perusahaan: Lebih dari 5000 pekerja
• Tunjangan dan Lain-lain: Asuransi Gigi, Asuransi kesehatan, Olahraga (contoh: pusat kebugaran), Waktu regular, Senin - Jumat, Formil (contoh: Kemeja + Dasi)