Duties and Responsibilities:
- Execution of validation/ qualification activities within the facilities according to Validation Schedule & Plans for Process Validation (PV), Cleaning Validation (CV) and Performance Qualification (PQ).
- Execute the planning and execution of on-going validation/ qualification and revalidation/ re-qualification of process improvements for manufacturing and packaging processes, equipment qualification and cleaning validation.
- Prepare and review the protocols and reports.
- Oversee the standard of protocol write-up and execution of validation and qualification activities by other cross functional team from various operational departments.
TECHNOLOGY TRANSFER AND SCALE-UP FOR NEW/ REVAMPED PRODUCTS
- To coordinate project planning, timelines and logistical programs to match new/ revamped product launches, contract manufacturing projects and process changes that are required for life cycle management of existing products.
- Coordinate and communicate the details of technical, quality and supply chain planning requirements during transfer of technology for new/ revamped products from the internal development team or other sites to manufacturing site.
- Works closely with Innovation & Development, Production, Production Planning, Engineering, QA, QC and Regulatory Affairs in regards to product scale-up, package design, technology transfer, process validation, and marketing of new products.
- Identify potential improvement plan and risk management for alternative source of supply for raw and packaging material to ensure consistent supply of good quality and cost effective materials.
- Review and approve the material evaluation and testing reports and recommendations for change control of new source of supply for existing or new materials.
- Coordinate with Supply Chain Management Team, inclusive of Materials/ Procurement, Supply Chain Quality Control (SCQC) and Finance Team to prioritize needs of material evaluation in supporting quality and cost effectiveness outcomes.
PACKAGING RELATED ACTIVITIES
- Communicate the product design requirements from Sales and Marketing or contract manufacturing clients to designers via agency brief.
- Coordinate with internal team for final artworks (FA) approval, which is inclusive of sales & marketing or external clients for brand design and artworks, Regulatory Affairs for label claims and regulatory requirements, Engineering and Quality Control functions for dimension and specific technical & quality control requirements.
- Coordinate and communicate with designated printers for specific technical requirements during first printing of new packaging materials.
- Communicate with Sales & Marketing and external clients for development of color standard for new printed packaging materials.
- Coordinate and execute the packaging related activities, including packaging design for new and revamped products to support new product submission and specific tender requirements.
- Provide technical support to Production and Supply Chain Quality Control (SCQC) for development and control of packaging material specification, including primary packaging materials (bottles, printed cardboard boxes, label, leaflets, PVC film and Aluminium Foil) and other packaging materials such as corrugated cartons, shrink-wrapping or bundling materials.
STABILITY RELATED ACTIVITIES
- Participate in specific assignment related to stability program such as coordinating studies in meeting more stringent stability study zoning requirements.
- Evaluate stability trends and prepare reports for assigned projects and initiate action reports or deviation reports for any applicable nonconformance.
- Recommend corrective actions not limiting to reformulation or shelf life reduction or product discontinuation.
- Provide a quality review process for data generated in the stability group as and when required.
- To participate in idea generation and execution of continuous improvement initiatives in methods, processes, materials, procedures and technologies.
- To provide technical support during trouble shooting of customer complaints and out of specification issues.
- To provide technical support to Production related to product robustness issue after technology transfer of products, processes and equipment.
- Bachelor degree in Science, Engineering or Technical related discipline.
- Minimum three (3) or more years of experience in the pharmaceutical or related industry.
- Possess knowledge of cGMP’s, pharmaceutical processing, process and equipment validation and documentation.
- Experience in one or more of the following areas: Solid dosage manufacturing, Liquids, Creams and Ophthalmic manufacturing and Packaging processes.
- Good interpersonal skills to interface with all levels of plant personnel and customers.
- Good technical communication skills, both written and verbal.
- Possess good project management and analytical skills.