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.

Key Responsibilities:

• Provide leadership to the manufacturing team to manage activities of Singapore Standardisation Programme, including administering, developing, and promoting of Singapore Standards.
• Plan, monitor, manage and complete standardisation projects to ensure launch of standards are timely according to the respective Standards Committees’ business plans and targets.
• Provide secretariat support for the Standards Committees, Technical Committees and Working Groups in the area of technical research for new standards/reviewing existing standards.
• Coordinate with government agencies, professional bodies and industry associations to plan, and monitor standardisation projects.
• Handle enquiries from enterprises regarding testing & conformance requirements stipulated in standards.
• Organise workshops/events/seminars to promote standards.
• Work with industry partners in the area of your responsibilities to identify critical and emerging standards to support national plans and enhance enterprise competitiveness, improve productivity and facilitate trade and market access.

Requirements:

• A recognised degree in Advanced Manufacturing / Aerospace / Engineering Science / Industrial & Systems / Material Science / Mechanical Design / Naval and Marine / Robotic Systems Engineering or diploma from a recognised institution with preferably 5 years of industrial experience.
• Results-oriented and able to execute projects effectively.
• Have strong interest in industrial Standards development and promotion.
• Possess excellent networking, analytical, communication, industry engagement skills.
• Proficiency in Microsoft Words, Excel, PowerPoint and minute writing is expected.
• A good command of spoken and written English is a must.

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