Job Title: Quality Assurance Specialist The post holder will be responsible for assisting the Quality Compliance Manager in the daily management of quality events including the analysis of post marketing activity arising from product complaints and queries. The post holder will assist in the management of the QMS, including authoring, reviewing and approving of GxP documentation and records as required.
This is a 1 year fixed term contract role.
KEY RESPONSIBILITIES Daily operation of the product complaint and medical enquiry process. Ensure all complaints are logged, assessed for regulatory reporting requirements, investigated and closed in a timely manner. Complete monthly reconciliation of complaints.Support and participate where required in the submission of product field alert and other safety reporting.Maintain a database of product information to ensure that the third service providers have the information they need to respond to customers' queries and circulate product complaint and adverse drug events in line with agreement contacts.Review, approve quality records (change controls, deviations, CAPAs, procedures, validation and other quality related documents). Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.Analyse and trend data, generate metrics and prepare reports for the Quality department and management, escalate any product, supplier or system issues found, tracking to resolution.Drive continuous improvement of processes to ensure quality is maintained while efficiency is optimized.Maintain a good understanding of existing and emerging pharmaceutical regulations and evaluate the impact on the private label business.Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business.Support cross-training opportunities and skills.Provide day-to-day department support activities as necessary to aid completion of project deliverables.Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross training as required.REQUIREMENTS Education/Training: Educated to degree level, ideally B.Sc. in Chemistry, Microbiology or other scientific discipline.
Experience: 5+ years pharmaceutical experience in a progressive multinational organization. Minimum 3 years in a Quality Assurance role.
Knowledge and Skills: Working knowledge of US and international Quality and regulatory requirements, including FDA regulations, ICH guidelines, and other relevant regulations.Experience in recording and handling of customer complaints and queries, along with working knowledge of complaint-related risk assessments and FARs.Experience in acting as Quality approver of Quality events (change controls, CAPAs and Deviations).Solid understanding and knowledge of cGMP and regulatory principles in a pharmaceutical manufacturing environment.Proven analytical skills and ability to transfer findings into report and presentation formats.Excellent organisational and time management skills.Excellent verbal, written, and interpersonal communication skills with ability to communicate at all levels within the organization.Ability to work independently and make decisions based on judgement and integrity.Excellent organisational skills with the ability to prioritise and manage projects within a team environment.Experience/Qualification in Root Cause Analysis. e.g. six-sigma Yellow/Green belt while not essential is desirable.PC/Equipment: MS Office; knowledge of Quality Tracking Software is essential. Experience in the operation/administration of GxP computer systems.
Work Environment/Physical Demands: Hybrid working model with the ability to work from home and in the general office environment. International travel may be required occasionally to meet business needs.
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