<div>Description:</div> <br> <div> <div class="olUlHelper pl10px"> MAXIMUM BILL RATE: 35.20ph <br/> <br/>9 month role with potential to extend <br/> <br/>Fully onsite position <br/> <br/>Primary Location* Slough <br/>Role Purpose & Scope* <br/>- Working as part of the QA Operations Documentation Control Team.
<br/>- The primary focus of this role is to perform Batch Consolidation (auditing) duties with regard to QC Biochemistry and QC Microbiology testing activities for Drug Product (DP) and Drug Substance (DS).
<br/>- The role requires the incumbent to co-ordinate the consolidation of all the QC testing activities and to perform an independent check that all the relevant activities have been completed and all release specifications have been met.
<br/>- Proactively issue documents and labels to Manufacturing based on the schedule and defined timelines obtained from customer departments <br/> <br/>Key <br/>Responsibilities* <br/>- Liaise with internal customers to ensure receipt of required information and maintain effective interdepartmental communication and collaboration.
<br/>- Work with the QA Operations team members, Manager and Team Leaders to enable continued improvement to QA quality systems / processes.
<br/>- To continually identify and implement improvements in safety, GMP compliance and efficiency.
<br/>- Perform Batch Consolidation duties with regard to QC Biochemistry and Microbiology testing activities for Drug Product and Drug Substance.
<br/>- Assist with preparatory work prior to audit and the provision of QC consolidated related information during customer and regulatory audits <br/>- Participate in projects to maintain and improve existing systems within the QA Operations Organization <br/>- Utilizing knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area.
<br/>- Issuing of approved/ effective GMP documents for use in Manufacturing (entering the unique document ID based on the issue list, printing from DMS and signing the issue list) ensuring that Manufacturing deadlines are met.
<br/>- Printing of labels for use in the Manufacturing process, including finished product labels.
<br/>- Checking accuracy of issued documentation and labels <br/>- Issuing of effective logbooks as required according to GMP procedures.
<br/>- Maintenance the Lonza Slough archiving system by checking received boxes adhere to GMP procedures, arranging for box collection and coordinating box retrieval as required.
<br/>- Leading and management of quality records e.g. Deviations, CAPA, Change Controls, Investigations <br/>- Authoring, Reviewing and approving GMP documentation <br/>- Prioritizing workload to ensure deadlines are met.
<br/>- Maintenance of training profile, ensuring that all required training is completed prior to performing an activity.
<br/>- Perform other duties as assigned/ required <br/> <br/>Key Stakeholders* <br/>Please specify the stakeholder positions the role will interact with <br/>- Stakeholder 1: Quality Control <br/>- Stakeholder 2: Manufacturing <br/>- Stakeholder 3: Quality Assurance and QPs <br/> <br/>Required Skills & Competencies* <br/>(e.g. technical, interpersonal, problem solving) Skills <br/> IT literate (MS Office Word, Explorer, Excel, Access, Outlook) familiarity with database entries <br/> Verbal and written communication skills <br/> Risk based decision making <br/> PQS experience <br/> Accurate data entry skills, high attention to detail <br/> Demonstrated workload prioritization skills, decision making and scheduling skills <br/> Ability to meet strict deadlines <br/> Good organizational and planning skills.
<br/> <br/> <br/>Competencies <br/> <br/>Agility <br/> Demonstrates an ability and desire to learn from experience <br/> Treats errors as a learning opportunity <br/> Is willing to take on new challenges <br/> Takes steps to adapt thinking and behavior to support change <br/>Business Acumen <br/> Seeks to understand the corporate strategy and how his/her business area contributes to the company s success <br/> Understands the impact of his/her own actions on his/her business area <br/> Expresses ideas that will improve his/her business area <br/> Uses knowledge of his/her business area to make accurate and timely decisions <br/>Collaboration <br/> Works as an active member of his/her team <br/> Generously shares information and knowledge with others on the team <br/> Demonstrates an openness to different perspectives by balancing listening and speaking <br/> Treats all co-workers and customers professionally and with respect <br/>Customer Focus <br/> Understands what internal and/or external customers need from him/her to deliver in his/her respective role <br/> Demonstrates an openness to receiving customer feedback <br/> Takes action to enhance customer satisfaction within the scope of his/her role <br/>Driving Results <br/> Consistently delivers goals while monitoring KPIs with supervisor <br/> Demonstrates persistence and motivation to overcome obstacles and challenges <br/> Ensures quality standards are maintained while delivering results <br/> Plans, prioritises and organises work to deliver on time <br/>Leadership <br/> Takes responsibility for his/her safety and that of others <br/> Takes responsibility for personal choices and behaviours <br/> Seeks feedback and reflects on his/her development needs in order to continuously improve <br/> Contributes to a positive work environment <br/> Acts as a reliable and dependable member of the team <br/>2.
Qualifications (Min.
requirements to perform assigned tasks) <br/>Education/Degree <br/>Required* Bachelors of Science (or equivalent experience) Field of Study Biology or related field <br/> <br/>Work Experience (If UK location - NO years of experience should be included) <br/>Area* Previous work experience in QA / GMP experience is useful though not essential Level* Entry Level: 0-4 years <br/> <br/>Accurate data entry skills, high attention to detail </div> <tr id = "skillBasedHiringFlag"> <td class="prompt">Enable Skills-Based Hiring</td> <td>No</td> </tr> <tr class="divider"><td colspan=2></td></tr> <tr fgId="CH - FTE Replacement (External Contractor) Reason"><th scope="row"><table style="width:100%;padding:0px;margin:0px;" class="noBorder"><tr><td class="cfNameCell" id="cf_descz25082713445850621442eb2">CH - FTE Replacement (External Contractor) Reason</td><td class="cfNameCell"></td></tr></table><p><b>Additional Details </b><ul><li>CH - FTE Replacement (External Contractor) Reason : N/A</li><li>Will Contingent Worker allocate time to project task codes?
: No</li><li>If yes, please enter exact project codes for allocation.
: -</li><li>Will this position require driving?
: No</li><li>Job Posting IR35 determination : Inside IR35</li></ul><table></table>