Research & Development

About the role

To lead and support activities related starting material including Raw material, Packaging material and Consumable material will be complied with compliance level.
To lead incoming raw material and packaging material team, ensuring work is completed on time, to defined procedures in compliance with Good Control Laboratory Practice, thereby providing continuous support to planning, warehouse, production, our consumer quality and customer service performance in the Bangplee factory.
To support and manage incoming, sampling and testing material activity.

Your responsibilities

• To manage raw material and packaging material team to stable production when to change manufacturing plan in production process.
• Follow up investigation, CAPA of any issues during using material in day-to-day manufacturing
• To ensure and maintain compliance level of supplier (reject rate, complaint rate etc).
• To ensure that packaging material test results are checked, approved, recorded and available for inspection in accordance with Good Manufacturing & Control Laboratory Practices
• To be responsible for maintain packaging material specification.
• Be responsible for all SOP related to packaging and raw material and safety.
• Co-ordinate with planning, production, warehouse, procurement, and quality team when raw material and packaging material encounter quality problem.
• To ensure that packaging material test results are checked, approved, recorded and available for inspection in accordance with Good Manufacturing & Control Laboratory Practices
• To ensure recompilation for raw material is aligned with sampling card.
• Be responsible to pass and release all packaging material complied in SAP system.
• Coach and mentor less experience analyst and staffs; check the quality of their work and help them resolve problems.
• To supervise team to solve analysis issue and instrument operate issue.
• To ensure that equipment, instrument are maintenance, calibrated of packaging material in QC laboratory.
• Accountable for ensuring laboratory investigations are thorough and accurate and escalation of confirmed Out of Specification (OOS) and Out of Trend (OOT) results in line with global standards and any local SOPs.
• To provide effective application of analytical investigation and change management within QC as defined in SOPs.
• To maintain Raw material sampling following HALAL requirement.
• To understand and follow all necessary Health & Safety systems and ensure that work is consistent with safe working practices.
• To communicate with packaging team and AQL when packaging specification problem.
• To provide and support raw material and packaging material rejection report to production, warehouse, planning, and supplier.
• To review packaging material report, summarize monthly packing material rejection, Right at First time (RFT)
• Co-responsible for housekeeping, cleanliness, and safety in the laboratory, also responsible for taking care of laboratory facilities to keep them in good condition and ready for use.
• Perform other related jobs that may be assigned by the supplier or superior.
• To responsibility of Halal Management Team
  • Develop and monitor manufacturing procedure of halal product to assure its consistency.
  • Coordinate for test every incoming material in accordance with halal certificate, specifications, and manufacturer.
  • Communicate with KAHI for each deviation and non-compliance of material and product in halal documentation.
  • Deliver internal halal training to all internal department member.

The experience we're looking for

• Minimum 2 years’ experience in Quality Control and/or Assurance of manufacturing site and / or technical centre preferably within a multinational Pharmaceutical Business.
• Through knowledge of GMP requirements for API manufacturer (ICH7) and PS9000 standard for pharmaceutical packaging material.
• Broad understanding of Healthcare and Pharmaceutical manufacturing operations business including raw materials and packaging material manufacturing and control.
• Knowledge of Quality responsibilities, systems, and standards.
• Knowledge and experience of Good Manufacturing Practice and Regulatory standards.
• Supplier/3rd party/Distribution centre (WH) Quality Management

The skills for success

• Flexibility in thinking and pragmatic problem-solving skills
• Proven experience in multifunctional / multinational project management
• Excellent communication skills with the ability to work on own initiative is essential for the success of this role. Be able to debate and negotiate with external supplier personnel
• Well-developed influencing skills. Diplomatic and tactful in difficult supplier situation
• Highly motivated and confident in external environments. Organised and able to deliver concise written or oral summaries to line manager
• Able to lead improvement plans with key suppliers, requires a good manufacturing knowledge and an understanding of business process
• Able to train and coach other auditors is preferably
• SAP experience/knowledge will be advantage

What we offer

Equality