The Quality Compliance Study Lead has the overall responsibility for onboarding new customers and ensuring QP Services activities are successfully delivered in clinical trials of new drug products. The Study Lead is the primary point of contact for stakeholders within Almac and clients.

Responsibilities

• Act as a principle contact for the customer requiring QP Services, keeping up to date with Clinical Trial legislation and providing expert advice in a consultancy capacity.
• Lead the QP Services activities at all stages, coordinating tasks and ensuring completion in line with the timelines agreed.
• Liaise internally within the QP and other internal departments globally to ensure the timely delivery of QP Services activities.
• Advise on QP related activities and responsibilities during the generation/revision of Technical Agreements.
• Escalate issues when appropriate.
• Record, collate and report customer specific KPIs, agreeing and implementing performance improvement plans where necessary.
• Follow through on all customer queries in a timely manner.
• Host /attend internal/external teleconferences/meetings, initiating QP related discussions for new or ongoing business, taking minutes, as required.
• Represent the QP Services Department during customer audits and sales visits, promoting Clinical Services expertise in Qualified Person related activities, in the generation of new or on-going business.

Criteria

• Bachelor’s Degree
• Experience with project management or facing clients in the pharmaceutical industry
• Excellent communication and stakeholder interaction skills
• Flexible
• Chinese or Japanese language skill are advantageous for interacting with Chinese or Japanese clients

Please note that the official title in the job offer may differ from advertised.

Core Responsibilities:

• To perform quality assurance functions with regard to the product (jet engine components), process and maintain quality management system while ensuring compliance with all related government agencies, aviation authorities and customers’ requirements and regulations.
• Establish quality procedures and quality control instructions.
• Liaise with customers / vendors / suppliers on non-conformance activities, perform root cause analysis and determine effective corrective actions to reduce or eliminate the cost of poor quality.
• Perform internal audits to evaluate quality system, products and processes (ISO9001 / AS9100 / NADCAP).
• Perform vendors’ and on-site audits as required.
• Uphold customers’ and regulatory authorities’ requirements.
• To carry-out other QA functions as required.

Qualifications:

• At least 2-3 years’ of relevant experience in Aerospace QA environment.
• Good analytical, communication and interpersonal skills.
• Meticulous attention to details, able to multi-task and commit to job.
• Familiar with ISO9001 / AS9100 Quality Management System requirements.
• Experience in using problem-solving tools including fishbone diagrams, FMEA and 5-whys methodology.
• Able to interact effectively with other functional departments such as Engineering and Production to resolve issues relating to products and processes.
• Familiarity with audit covering special processes including heat treatment, plasma coating, NDT would be a plus
• Experience in metallurgical laboratory evaluations would be advantageous

Education Requirements:

• Degree / Diploma in Mechanical / Aeronautical Engineering

Job Description:

Spare Parts

· To deliver spare parts service to internal and external customers within the Service level agreement (SLA)

· To monitor processes & procedures for service parts operations such as advanced / standard replacement, repair & return, analysis and return process

· To monitor and make sure all the loaned parts to customers and engineers were return according to procedure

· Involve in customs, freight matters e.g. freight bill negotiation / verification, reviewing freight rate and shipping company for all the international inbound / outbound shipment

· To monitor and manage the performance of outsources / non outsourced service logistics operations to ensure service is delivered within KPI

· Guarantee service parts stock data accurate, reduce the company assets safety risk and standardize the service parts management operations

· Achieve KPI set by Management e.g. On time service delivery, Inventory Turnover Rate and maintain spare part stock accuracy.

· Monthly reporting e.g. inventory, borrowing, repair & return, analysis reports

Quality & Operation

· To audit quality of safety security domain and improve network change quality

· Communicate and audit engineers to ensure engineers comply with the network change process and KCP as well as D&S Cyber Security Management Requirements

Job Requirement:

· Diploma or bachelor degree in warehouse / inventory management for spare part position

· Min. 1 year relevant experience in warehouse / inventory management is preferred

· Excellent organisational skills

· Good interpersonal and communication skills, able to interact with internal / external customers

· Need to be able to travel within Singapore to different offices / warehouse

· Good command of English and Chinese is required to be able to communicate with various speaking business associates

· To be able to work independently and make skillful decisions