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Quality Assurance Specialist
Location:
Guildford, Surrey
Description:
Are you a detail-oriented QA Specialist with a passion for maintaining the highest quality standards? Are you ready to play a crucial role contributing to the success of a great organization? If your answer is an enthusiastic “yes” then please keep reading! Our Quality Assurance group is looking for a new QA Specialist to join their team. Who is MedPharm? We are a team of scientists and innovators developing new formulations and models for the topical and transdermal drug market. We have established a worldwide reputation for delivering exceptional solutions over the past 20 years. Our commitment to excellence drives us to maintain rigorous quality assurance standards, and we're seeking a QA Specialist to join our team. What does a QA Specialist do? The QA Specialist is a vital member of our team supporting the day-to-day QA actions to ensure quality and compliance for GxP work and batch release activities. This includes audits of study activities, study reports, vendor evaluations, facilities against applicable government agency regulations/guidelines, as well as our Company's policies, procedures and industry standards. They also participate in the review and approval of change controls, deviations, OOS, assessment of potential root cause and Corrective Action and Preventive Action (CAPAs) associated with Significant Quality Issues, as needed. What are we looking for? We are seeking an experienced individual who can seamlessly transition into a small team and contribute to its success. You should have a strong attention to detail, be a go-getter, and be continuously striving for self-improvement. You should be knowledgeable about government regulations. Your expertise will play a pivotal role in maintaining our quality programs, facilitating internal audits, and driving continuous improvement initiatives. You need to have at least two years of experience in QA. Perks of working at MedPharm Paid to work with amazing people 25 days annual leave per year plus bank holidays 24/7 Employee assistance programme offering confidential well-being support and advice Leadership development programme Referral bonus up to £1500 Salary Exchange programme Discounted gym membership at Surrey Sports Park Free office snacks and drinks Regular social events and company-organised activities including Netball, Football and running clubs. Friendly working atmosphere Work/life balance Free prescription lab safety goggles Private medical insurance or health cash plan schemes for qualifying employees Life assurance/Death-in-service scheme Position Summary Position title: Quality Assurance Specialist Reports to: QA Lead Location: Guildford, Surrey (GU2 7AB) - Please check commute before applying Review and approve of change controls, deviations, OOS, CAPAs, audit comments and other related quality records and providing QA input into their generation. Support internal audits of facilities to ensure compliance to GxP and other applicable standards. Maintain the quality programs for the QA department including but not limited to, document control, supplier qualification, Technical Agreement and internal/external audit program. Development, review and revision of company standard operating procedures. Assist with the issue of Quality documentation such as standard operating procedures (SOPs) and forms, via ETQ where necessary. Support the management of retention and archiving of records Training and implement QA procedures for compliance with GxP. Participate in continuous improvement activities. Audit raw data where appropriate to ensure that the work has been completed to GxP. Liaise with all staff; communicating information and updates as appropriate. Approve restricted document types on behalf of QA Ensure that all documentation, computer data and records are stored appropriately. Approve specifications, sampling instructions, test methods and other Quality Control procedures. Review batch manufacturing records prior to manufacture. Review and approve completed batch manufacturing records post-manufacture. Review and monitor suppliers of materials. Approve or reject, as appropriate, starting materials, packaging materials, and intermediate, bulk and finished products. Monitor compliance with the requirements of Good Manufacturing Practice. Review and compile manufacturing batch records and associated data ready for QP batch release Be initial contact in the team in the absence of Head of QA and or QA Lead. Oversee the activities across the QMS reporting any issues to the Head of QA. To carry out GLP documentation reviews/study inspections as required. To act as GLP Archivist and have oversight of these activities. To adhere to MedPharm H&S policy and COSHH regulations at all times and to ensure the safety of others in any procedures or tasks performed. To perform any other tasks at the request of MedPharm senior management appropriate to the job function Candidate Requirements Education Bachelors degree with 2+ years of relevant experience, education may be used in lieu of experience Experience/Traits/Skills Knowledge of batch release process and root cause analysis Knowledge in batch release support (review of BMRs, data etc) Knowledge of QMS management including deviations, CAPAs and change control Previous experience in pharmaceutical industry CMO, CRO or big pharma (exposure to manufacturing ideal) Demonstrated ability to review, revise and perform procedures associated with quality assurance and resolve issues of moderate complexity Must have a meticulous approach to work and be highly organized and extremely driven. Good communication skills both written and oral are vital Must be able to multitask, manage time efficiently and be able to prioritize Must be able to work independently and in a team environment Must have a proactive and self-starting approach, consistently taking initiative MedPharm is unable to offer any form of visa sponsorship at this time. Please be aware of phishing scams posing as MedPharm and offering opportunities in exchange for payment. Your personal details and credit card details should not be shared, especially if you are suspicious of the source requesting it. By submitting your application to MedPharm Ltd, you confirm you are not presently debarred, suspended, proposed for debarment by any Federal, State or local agency. Note to Recruitment Agencies: Please do not submit resumes to any of our job opportunities advertised on our website, or directly to any employee of MedPharm. MedPharm will not be responsible for any fees that may relate to unsolicited resumes. 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Company:
Medpharm
Posted:
July 10 on The Resumator
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