Pros: exempt employee, professional comunication, good relations with the others people.
Cons: distance to drive
Quality Compliance Specialist
• Investigates customer complaints, external complaints conduct Internal Audits, approve regulatory CAPA, Vendor Certification, Quality Agreements, Annual Product Review / Report for Finished Product and Systems and site licenses.
• Supports readiness of the facility for Regulatory Inspection. Assists the Associate Director Compliance and auditing during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
• Conducts internal / external audits following annual site plan with respective reports and actions items from areas impacted during the audit.
• Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management.
• Communicates frequently with management and informs, via frequent written reports, any problem that might affect the quality of the product or the compliance state of the facility.
• Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
• Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
• Aligns facility Quality Systems with GMP’s, Regulatory Standards and domestic and international markets requirements.
• Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.
• Review Quality Agreements.
• Support Regulatory Request for others Sites.
• Generates, – more... reviews and implements departmental procedure and forms to assure compliance with current practices or GMP’s trends.
• Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.
• Manages document including record retention program, compliance and custody of SOP’s and review / approval / issuance of master documentation related to operational areas and ; evaluates compliance of all procedure (SOP’s) and master documentations and BMS Policies.
• Provides guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.
• Updates the Site Master File (SMF) and assists our regulatory section to handle and update documentation as part of our filing.
• Coordinates Fact Findings documentation following Worldwide Quality and Compliance Directive and conducts root cause analysis to guarantee that underlying problems are identified and resolved.
• Leads Field Alert Report (FAR) and Recall Investigations and provides tracking to any Site Planned deviation.
• Executes and implements domestic/international regulations and BMS guidelines and implements the corresponding actions to assure that the facility meet the establish requirements.
• Supports the Quality Risk Management program at the site participating in multidisciplinary teams.
• Preparation of monthly Quality Council meeting and presentations.
• Ensures the site has an Internal audit program and that all system audits of approved Third Party Manufacturers and others vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program.
• Manages the product complaints that include performing complaint investigations in a timely manner, instituting corrective actions where appropriate and identifying product complaint trends.
• Verifies BMS and WWQ&C Policies and Guidelines and site GMP compliance policies and procedures are addressed. – less