Pharma Process & Quality Improvement Lead

Duopharma Biotech Bhd Group of Companies.; Klang City, Port Klang; Sur place; MYR 180 000 - 240 000; Plein temps

Résumé du poste

Duopharma Biotech Berhad is seeking an experienced professional to lead product quality improvement initiatives, manufacturing process optimisation, and technology transfer projects within a GMP-regulated pharmaceutical environment. You will manage formulation trials, evaluate materials, and collaborate with cross-functional teams to implement product and process improvements.

The role requires a minimum of 6 years in the pharmaceutical industry, with strong knowledge of GMP, quality systems,

Qualifications

• Bachelor's Degree in Life Sciences, Pharmaceutical Sciences, Pharmacy, Chemistry or related discipline.
• Master's Degree in Pharmaceutical Sciences or Chemistry is an added advantage.
• Registered Chemist (IKM) or Registered Pharmacist with the Pharmacy Board Malaysia is preferred.
• Minimum 6 years of experience in the pharmaceutical industry within a GMP-regulated manufacturing environment.
• Experience in formulation development, manufacturing process improvement, analytical method development, technology transfer, or pharmaceutical R&D is highly preferred.
• Experience with Sterile (SVP) and/or Oral Solid Dosage (OSD) products is an added advantage.

Responsabilités

• Lead formulation trials and product quality improvement projects for existing pharmaceutical products.
• Evaluate alternative and new raw materials to ensure suitability for manufacturing and product performance.
• Review trial results, analyse findings, and provide recommendations to support continuous improvement initiatives.
• Monitor project progress and ensure timely completion of assigned activities.
• Manage pilot batch manufacturing for product variations, site changes, and stability studies.
• Coordinate product scale-up and technology transfer from R&D to commercial manufacturing sites.
• Support product transfers to new manufacturing facilities while ensuring compliance with quality and regulatory requirements.
• Collaborate with cross-functional teams to ensure smooth implementation of technology transfer activities.
• Prepare and review technical documents, reports, protocols, and supporting documentation required for Regulatory Affairs, QA, and other stakeholders.
• Maintain complete and traceable project documentation in accordance with GMP and QMS requirements.
• Author investigation reports, design review documents, trial reports, and technical summaries to support regulatory submissions and product improvement initiatives.
• Ensure compliance with QMS and eQMS requirements, including Change Control, CAPA, QRA, FMEA, SOPs, Work Instructions, and internal audits.
• Oversee maintenance and calibration of formulation laboratory equipment.
• Support analytical method development and troubleshooting in collaboration with Quality Control.
• Lead procurement and acquisition of laboratory equipment, consumables, and technical resources.

Connaissances

GMP knowledge

Project management

Technical writing

Cross-functional collaboration

Quality systems

Formation

Bachelor's Degree in Life Sciences/Pharmaceutical Sciences/ Pharmacy/ Chemistry

Master's Degree in Pharmaceutical Sciences or Chemistry

Description du poste

Duopharma Biotech Berhad is seeking an experienced professional to lead product quality improvement initiatives, manufacturing process optimisation, and technology transfer projects within a GMP-regulated pharmaceutical environment. You will manage formulation trials, evaluate materials, and collaborate with cross-functional teams to implement product and process improvements.

The role requires a minimum of 6 years in the pharmaceutical industry, with strong knowledge of GMP, quality systems,