RSSL Senior Quality Officer

Reading Scientific Services Ltd (RSSL) is a cutting-edge Contract Research Organisation (CRO), providing research, analysis and consultancy to the pharmaceutical, healthcare and food 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 were recognised as OBN’s Best CRO, Women in Business Enlightened Employer and Business of the Year award winners.

Enriched by our parent company Mondelēz International, our diverse team includes 22 nationalities from 300 members, creating a family feel as we strive towards our mission of science enhancing lives.

You provide hands-on assistance to support the operation and goals of the laboratory by planning and conducting experiments and applying your understanding to analyze results. With guidance, you plan and implement assigned projects.

This position is responsible for supporting the quality team in maintaining and improving RSSL quality system in Reading UK through:

• Maintaining RSSL UK compliance to cGMP standards for the pharma industry and RSSL accredited status to ISO 17025 for the food industry
• Support RSSL laboratory staff with advice, guidance and knowledge of the appropriate quality system requirements
• Conduct internal audits and follow up on findings

This role is available at flexible seniority: it can provide a step up for someone with prior Quality experience, or can be a more junior role for someone with some lab experience looking to get into Quality for the first time.

Responsibilities

• To maintain and improve the RSSL quality system processes by review and approval of some QMS processes e.g deviations, simplified change control processes, issue and withdrawal of the controlled documentation, assist is supplier approval and checking of equipment calibration records and document archiving.

• Audit the RSSL laboratories or department against the relevant Quality Systems (UKAS, GMP) according to the audit plan, document the audit detailing the findings and agreeing with the appropriate staff the necessary corrective actions. Follow up any non-compliances and ensure that corrective actions have been taken prior to closure. Prepare, distribute and administer the audit report for the areas audited.

• Assist with preparation of data for departmental quality review meetings, quality lead meeting, client audits, external regulatory inspections attending audits and capturing actions and minutes as and when required.

• 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.

• Support training on quality matters, delivering ad hoc and planned training on Q-Pulse and other quality matters.

• Take a proactive role in continuous improvement program.

Requirements

• Educated to degree level or equivalent experience in a relevant scientific field
• Some experience with basic laboratory equipment
• Meticulous attention to detail
• Strong written and verbal English skill
• Experience of working in a regulated environment (preferred)

Elements of this role can be done from home but certain duties require the successful candidate to work hands-on with equipment and as such the role will be split between home and on-site working in Reading.