Section Head - Quality Control Raw Material/Packing Material (RM/PM)

Ranbaxy Malaysia; Kota Sarang Semut; On-site; MYR 250,000 - 300,000; Full time

Job summary

Ein international tätiges Unternehmen im Bereich Pharmazie sucht einen erfahrenen Section Head für die Qualitätskontrolle von Roh- und Verpackungsmaterialien. In dieser Schlüsselposition sind Sie verantwortlich für die Überwachung der QC-Operationen, die Sicherstellung der Einhaltung von cGMP-Richtlinien und die Genehmigung von Prüfberichten. Sie werden an der Koordination von Technologieübertragungen während neuer Produkteinführungen beteiligt sein und die Dokumentationsanforderungen für regulatorische Einreichungen unterstützen. Dies ist eine spannende Gelegenheit, Teil eines der führenden Unternehmen in der Branche zu werden, das sich durch Innovation und Qualität auszeichnet.

Qualifications

• Erfahrung in der Qualitätskontrolle in der pharmazeutischen Industrie.
• Kenntnisse in Good Manufacturing Practices und Dokumentationsstandards.

Responsibilities

• Leitung der QC-Operationen für Roh- und Verpackungsmaterialien.
• Überprüfung und Genehmigung von Prüfberichten und Analysezertifikaten.

Skills

Qualitätskontrolle

Dokumentationspraktiken

Analytische Fähigkeiten

Regulatorische Compliance

Education

Bachelor in Pharmazie oder Chemie

Master in Pharmazie

Tools

Laboranalysegeräte

Dokumentenmanagementsysteme

Job description

Section Head - Quality Control Raw Material/Packing Material (RM/PM)

Add expected salary to your profile for insights.

Manage QC operations for receipt, testing, and approval/rejection of all incoming RM/PM (Raw materials and Packing materials).

Plan daily RM/PM sampling and testing schedules.

Ensure timely testing and release of all test samples (RM/PM) as per approved specifications, STP, and Customer requirements.

Review and approve RM/PM data summary reports and Certificates of Analysis for accuracy and completeness.

Maintain documentation compliance as per SOP on Good Documentation Practices and cGMP Guidance for laboratory control and management.

Ensure laboratory testing is approved and contracts for analysis are available before utilizing services.

Participate in OOS/OOT/Laboratory investigations, conduct detailed investigations, and implement appropriate CAPA.

Review analytical documentation and approve Certificates of Analysis.

Coordinate technology transfer products during new product launches.

Review pharmacopoeia specifications and manage document control systems at the plant.

Review and approve specifications, sampling instructions, test methods, and other QC procedures.

Monitor laboratory project and other expenses, including capital investments.

Support regulatory operations for submissions, including timely RM/PM related documentation.

Respond to internal/external audit observations related to laboratory computerized systems and ensure compliance.

Implement and ensure adherence to quality policies, standards, and procedures for computerized systems at the site.

Validate GxP computerized systems and maintain their validated state throughout their lifecycle.

Assist in drafting responses to audit observations for computerized systems to ensure compliance.

How do your skills match this job?

Sign in and update your profile to get insights.

Your application will include the following questions:

• What is your expected monthly basic salary?
• Which of the following qualifications do you possess?
• How many years of experience do you have in a Quality Control role?

Company: Pharmaceuticals, Biotechnology & Medical, 101-1,000 employees

Ranbaxy (Malaysia) Sdn. Bhd., a SUN PHARMA company, is an international pharmaceutical company producing a wide range of quality, affordable generic medicines. In Malaysia, we are ranked among the Top 10 pharmaceutical companies. We have a strong sales and marketing team and enjoy significant brand recognition among doctors, hospitals, and retail pharmacies.

Our manufacturing unit is located in Sungai Petani, Kedah. It produces Oral Dosage Forms (tablets, capsules, dry syrups) and is approved by the Ministry of Health. It features an independent Quality Unit to ensure product safety, identity, strength, purity, and quality. The facility includes a Technology Development Laboratory with smaller capacity manufacturing equipment to deliver products with the intended quality attributes.

To expedite your application, please include any relevant details that prompted you to report this job ad as fraudulent, misleading, or discriminatory.

Research careers and find all the information and tips you need on career advice.