! Quality Assurance Associate - Global Bio-Pharmaceutical!
Planet Pharma
slough, england, United Kingdom
! Quality Assurance Associate - Global Bio-Pharmaceutical! Location: Onsite close to Slough FTE: Full time - 9 months (Company average tenure over 4 years. Role will have the view to extend) Start date: ASAP Rate: Very good rate Job Description Planet Pharma are working with a leading contract development and manufacturing organization (CDMO) serving the healthcare industry. They collaborate with a wide range of customers, from emerging biotechs to global pharmaceutical companies, to transform therapeutic discoveries into life-saving treatments. They specialises in biologics, small molecules, highly potent active pharmaceutical ingredients (APIs), and cell and gene therapies, offering integrated solutions across the entire treatment lifecycle. Objective : Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance, and senior QA leadership. Ensure quality is maintained at an appropriate level to meet customer and regulatory expectations, enabling the site to achieve relevant targets. This is achieved by assessing compliance with site PQS and principles of GMP, auditing documentation generated during manufacturing, development, and laboratory processes, and escalating non-compliance through PQS, site governance mechanisms, and senior QA leadership when required. To provide direct review of documentation created during manufacturing, development, and laboratory processes. Advise on best practices for document completion, review, follow-up actions, and escalate issues when necessary. Serve as a point of contact for general queries about Quality, escalating concerns as required. Use knowledge of quality procedures to identify and report non-conformances, resolving issues through coordination with relevant personnel. Apply expertise in GMP and quality processes to manage and escalate critical compliance matters via site QMS processes, such as deviations and CAPAs. Actively identify, suggest, and engage in continuous improvement activities. Mentor and coach colleagues on cGMP practices to maintain a high-quality environment. Ensure a state of audit readiness is upheld at all times. Proactively contribute to PQS process improvement initiatives and projects. Requirements: Previous work experience in QA / GMP experience is useful though not essential IT literate (MS Office Word, Explorer, Excel, Access, Outlook) familiarity with database entries Verbal and written communication skills Risk based decision making PQS experience Accurate data entry skills, high attention to detail Demonstrated workload prioritization skills, decision making and scheduling skills Ability to meet strict deadlines Good organizational and planning skills. If this role isn t suitable for you, please let us know if you can refer anyone any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help! About Planet Pharma Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.