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Reading Scientific Services Ltd (RSSL) is a cutting-edge Contract Research Organisation (CRO), providing research, analysis and consultancy to the food and pharmaceutical sectors. Whether we are creating new products, validating medicines or solving investigations, we take pride in being a leader in our field, serving clients from across 60 countries.   
 
In 2019, we’ve been recognised as Enlightened Employer, Women in Business and Thames Valley Tech finalists and in 2018 one of our family earned the Food & Drink Federation’s Scientist of the Year. Enriched by our parent company Mondelēz International, our diverse team includes 23 nationalities from 300 members, creating a family feel as we strive towards our mission of “Science Enhancing Lives”.

This position is responsible for supporting the quality team in maintaining and improving RSSL quality system in Reading UK through:
• Maintaining and developing RSSL UK compliance to cGMP standards for the pharma industry and RSSl accredited status to ISO 17025 for the food industry
• Representing RSSL at client audits, demonstrating and promoting the quality systems
• Support RSSL laboratory staff with advice, guidance and knowledge of the appropriate quality system requirements
 

Key Responsibilities:

Technical 

. To maintain and improve the RSSL quality system processes by review and approval of QMS processes e.g OOS investigations, change control, deviations, method validation, issue and withdrawal of the controlled documentation. Maximising the efficiency through use of Q-Pulse.
. Assist at audits by clients and at regulatory inspections, MHRA and UKAS. Acting in a professional manner and exemplifying RSSL corporate image.
. Conduct external audits of service providers, complete audit reports, create observations in Q-Pulse and manage their timely completion as required.
. Perform internal audits of the laboratories and systems to ensure ongoing compliance with the regulatory requirements and internal procedures 
. Participate in annual quality reviews in the laboratories, prepare the minutes , create the actions in Q-Pulse, follow up and review their completion 
. Assist in compiling the KPIs for RSSL laboratories and creating the reports 
. Lead projects to improve the efficiency and effectiveness of the quality management system
. Takee responsibility for at least one of the focus areas of in-house Quality training (to the business, coordinating training sessions, producing or assisting and collating training materials and delivering some of the training), in-house and external equipment calibration (managing the calibration programme and working with the calibration officer to ensure all calibrations are performed on time and to the appropriate standard) and or in-house and off site document archiving (liaising with the laboratories for transfer and retrieval of archive boxes and for managing the retrieval and disposal / return of documents at the end of the archive period). 
. Know the ethical and legal compliance responsibilities of the position; raise questions and concerns when faced with an ethical or compliance issue; apply integrity in all aspects of professional conduct.

Communication & Influence

. Review contractual documentation from RSSL UK customers and vendors, e.g. Supplier questionnaire, Confidentiality Agreements etc.
. Take an active role in producing training materials and delivering training as required 
. Take a proactive role in continuous improvement program 
. Confident communication when facing regulatory and client auditors

QEHS

. Work to the highest standards of safety and quality by ensuring that appropriate COSHHs, risk assessments and SOPs are understood and followed.
. To complete assigned quality actions on a timely manner
. To maintain a clean, tidy and safe working environment.
. To understand and work to the requirements of GMP and UKAS.
. Ensure training records are accurate.

Qualifications
 
Knowledge: including education, qualifications and training:

. Educated to Degree / HNC level in a relevant scientific discipline or equivalent relevant experience in a laboratory.
. Good understanding of basic lab equipment


Skills/Leadership Competencies

. Accountable, honest, hardworking and able to work efficiently in a team
. Flexible and adaptable to meet customer/business requirements.
. Meticulous attention to detail and an ability to follow written instructions.
. Good written and verbal communication skills.
. Self motivated, enthusiastic and quick to learn.
. Well organized and capable of working on multiple activities concurrently.
. Computer literate in standard MS office applications

Experience

. Experience of working in a regulated environment.
. Experience of conducted internal audits to GMP or ISO 17025 standards
. Experience of controlled document management
. Experience or good level of knowledge in at least one of the 3 focus areas (in-house training, equipment calibration or document archiving) preferred

Languages

. Fluent English, written and spoken

We pride ourselves on having a high performing and collaborative culture where we offer support and development to enhance your career and develop your knowledge and skills.

In return for your commitment, drive and enthusiasm, we offer an attractive benefits package within a highly successful International business that offers financial rewards and resources, including bonus scheme, contributory pension, life assurance, generous holiday allowance and a flexible benefits programme.

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