qa operations support manager quality assurance manager gmp glp change control complaint management documentation permanent surrey k a growing specialist pharmaceutical company are currently seeking an experienced qa operations support manager at their site in surrey as a key member of the team you will be responsible for managing the quality assurance quality control functions that include the documentation control system for the operations organization complaint management internal external auditing batch monitoring responsibilities and quality systems training responsibilities responsible for managing oversight of the processes for the controlled documentation system including qa documentation contractor documentation laboratory testing results master lists packaging samples and internalexternal audits responsible for coordinating revision of various quality system documents such as standard operating procedures sops and quality and operations policies qops responsible for coordinating revision of all operations department sopsqopsforms to ensure compliance with cgmps responsible for customer complaint management including receipt investigation responses and semiannual complaint analysis recommends corrective and preventive action and tracks to ensure implementation responsible for nce oos and contractor deviation reporting and management recommends corrective and preventive action and tracks to ensure implementation conducts internal audits to ensure compliance with regulatory agency requirements cgmps dea regulations departmental specifications and sops ensures action items are tracked and implemented conducts external audits to ensure compliance with regulatory agency requirements cgmps dea regulations departmental specifications and sops ensures action items are tracked and implemented ensures minutes of the quality and operations steering committee are completed and approved in a timely manner oversees the site training program ensures employees qualified persons consultants and production contractors are trained appropriately assists in the development of product specifications sampling plans test methods investigations validations or control mechanisms as needed responsible for assisting with project management as requested responsible for batch manufacturing responsibilities including observation of manufacturing process creating batch noted tracking of noveon sheering times by batch and primary contact for manufacturing issues sheering decisions act as primary contact for manufacturing packaging laboratory issues at all contractors act as primary cmcregulatory contact for compilation of updates and modifications for nda filing education bachelors degree experience extensive experience with documentation change control internal audits and complaint investigation microsoft office and word required knowledge must be familiar with good manufacturing practices fda requirements and other regulatory agencies within the pharmaceutical industry competency in computer interface skills and word processing required proficient in typing with accuracy and familiarity with formats required salary k benefits this job was originally posted as wwwtotaljobscomjobseekingqaoperationsmanagerauditinggmpqmspharmaguildfordkjob