QA Auditor/Compliance Specialist Devens MA Our client, a major pharmaceutical company in Devens MA is seeking a QA Auditor/Compliance Specialist on a contracting basis. Please read over the details and let me know if this is something that you would be interested in.
*Description: * The candidate will provide operations with the appropriate service and advice to assure that manufacturing activities are carried out within the framework of corporate/governmental policies and regulations (cGMP's) and; to assure that site quality systems are in place for regulatory compliance. the incumbent works with minimum supervision. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing *Responsibilities:* - Completes investigations for returned goods, damaged goods, process deviations and laboratory investigations. - Recommends material or product disposition, if required. - Prepares annual product reviews report for each bulk drug substance and pharmaceutical finished product. - Recommends our regulatory section to handle and update documentation intended for regulatory agencies (i.e. FDA) - Reviews, evaluates and approves plant operating documents, such as SOP's, master batch records, manufacturing change control and process deviations. Maintains documents in an organized and traceable manner. - Evaluates specification, recommends and submits changes when necessary to the specifications committee. - Provides escort/assistance in managing all aspects of regulatory and corporate inspections (FDA, EMEA, etc.). - Recommends lots for stability submission. - Ensures compliance of all procedures (SOP's) to avoid regulatory issues. - Provides advice and service to all operating departments as to assure compliance with cGMP's and other regulations. - Investigates customer complaints, issues the corresponding report indicating possible cause and recommending solutions. - Conducts and documents GMP and/or SOP's training as required. - Completes investigation of material for rejection. - Performs formal internal audits and pre-approval inspections of manufacturing, laboratory and warehouse operations for cGMP's compliance. Regularly reports as necessary and follows up on observed deficiencies. - Evaluates inventory frequently to drive closure of pending items to assure timely disposition. - Assists in the Supplier Qualification/Certification program. - Performs readiness exercises for government inspections. - Assists in the review of manufacturing records and assign material disposition when required. *Best Regards* *Ankit Nagar* *Talent Acquisition Manager || TEK Inspirations LLC* *Phone: 713 234 6351* *Email ID: [email protected] <[email protected]>* *Gtalk: [email protected] <[email protected]>* *Save trees. Print Only When Necessary* *This communication, along with any documents, files or attachments, is intended only for the use of the addressee and may contain confidential information. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of any information contained in or attached to this communication is strictly prohibited. If you have received this message in error, please notify the sender immediately.* -- You received this message because you are subscribed to the Google Groups "US_IT_ Jobs" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/chandrakants. For more options, visit https://groups.google.com/d/optout.
