WALKER COLE INTERNATIONAL

Responsibility

• develop Regulatory strategies for innovative and rapid access to new markets
• tracking and handling samples, and ensuring the management of this process is both efficient and quality controlled
• drafts and leads the implementation of the Microbial Contamination Control Strategy documentation
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• manage routine Manufacturing Authorisation maintenance activities for National and MRP procedures including compilation and submission of variations and renewals
• shipping samples to global locations such as to the company’s partners and CROs
• ensure submissions of Marketing Authorisation Applications in European and Global territories can be successful
• communicating with both internal and external stakeholders
• leading and approving quality risk analysis , reviews related change Requests, deviation/investigations, CAPAs as a SME for Microbiology issues
• managing centralised prodceudres and paediatric studies to aid in the regulatory submission process
• participate and provide SME inputs for ongoing development and delivery of gowning and aseptic awareness training for all GMP manufacturing staff
• as the Compound Manager, you will be preparing samples or bioassay plates using both manual and automated procedures
• leading cross-functional/site reviews and update local documents in accordance with Microbial contamination control program/strategy
• leading in complex deviation investigations, contamination and microbiological investigations, change controls, CAPA proposals and closure of non-conformance reports
• supporting the preparation and follow-up of internal/external audits and Regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control strategies and associated mitigations and improvements

Requirements

• environmental Monitoring
• scientific Background
• chemistry
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• biosampling

Earnings for position manager

Current offers for the position:

Responsibility

• to co-ordinate projects, monitoring progress whilst ensuring project goals and client expectations are met
• to lead the Clinical Supplies project team and technical meetings for assigned projects
• have ownership over the entire life cycle beginning with customer orders through to the delivery of company products
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• manage the billing process in relation to distribution, returns and destruction until the project is completed
• mentor Associate Project Managers
• to support business development and also the estimation of new quotations and resupplies
• overall improvement, streamlining, and continuous improvement of the distribution team
• mentor the Associate Project Managers
• communicate milestones of the project, its activities and assign internal and external responsibilities to ensure the project meets client requirements and time frames
• the Clinical Supplies Project Manager must access clinical protocols, contracts, study specifications as well as other documents, to ensure risks are mitigated

Requirements

• distribution
• logistics
• manufacturing
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• project Management

Earnings for position project manager

Current offers for the position:

Responsibility

• welcoming visitors and vendors, providing refreshments for visitors and arrange taxis as required
• ensure the proper operation of the visitor and staff booking in and out system
• take incoming phone calls and route as needed
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• deal with incoming and outgoing post and courier requirements
• assist with organization of Company social events and celebrations, as well as large meetings

Requirements

• booking
• calls
• microsoft Excel
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• microsoft Office
• supportive

Earnings for position receptionist

Current offers for the position:

Responsibility

• providing lab support for the Biology team by completing routine support functions
• preparing basic solutions e.g. buffers, protein scaffolds
• collating and overseeing ordering/goods in activities
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• preparing protein batches
• undertaking a project to develop, integrate and implement a framework and process for sample management
• growing and maintaining tissue culture cells
• providing QC analysis
• preparing necessary paperwork using MS Office suite

Requirements

• biotechnology
• chemistry
• laboratory
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• tissue Culture

Earnings for position laboratory technician

Current offers for the position:

Responsibility

• managing the batch review process ensuring timely batch review and release
• ensure review of all Quality and production batch documentation is completed correctly, to achieve an elevated level of service and GMDP
• in addition to direct line management duties the post holder is expected to develop the skill sets within the team
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• provide QA support to the business during root cause analysis investigations
• to schedule and manage the Quality Operations Team with responsibility for resource allocation, day to day objectives setting, appraisals and staff performance management
• drive the performance of the Pharmaceutical Quality System across the business
• work with the Head of Quality to optimize QA performance and drive continuous improvement
• ensure daily issues are addressed and raised in a timely manner
• enhancing team and inter departmental interactions within the business whilst motivating the group to deliver an effective and compliant service to operations
• support activities required to effectively maintain the company Pharmaceutical Quality System
• ensure operational metrics are provided to agreed time scales and to provide performance measures for the PQS to the Head of Quality
• ensure resources are available to monitor alerts for potential overdues for Complaints, CAPA, GDP issues, Deviation and Change Control
• support and represent the business during regulatory and customer audits
• sets performance objectives/goals for quality operations team and regularly evaluate employee's performance
• evidence of timely completion of ad hoc and other tasks as assigned
• manage and perform GEMBA walks on a frequent basis to monitor the housekeeping practices in the area and to evaluate GMDP and DI compliance
• participate in reviews of OOS and RCAs in a timely manner and timely escalations to HOQ/QP as required

Earnings for position operations manager

Current offers for the position: