This position is responsible for maintaining several elements within the Quality Systems frame work to ensure the Site compliance with current and forthcoming Biopharmaceutical and Medical Devices industries Good Manufacturing practices regulations and BMS policies. Incumbent must comply with Corporate and HR Policies, FDA, GMP, internal/external audit, and any other regulatory requirements. Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Investigates customer complaints, external complaints, conduct Internal Audits, approve Regulatory Corrective Actions and Preventive Actions (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. Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP's trends. Provides support to the Associate Director Compliance and Auditing in the preparation of the area Budget, and on the decision making process related with compliance issues. 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 documentation with regulations 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/Biological License Application (FAR/BLA) 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. Provides support to the Associate Director Compliance and Auditing in the preparation of monthly Quality Council meeting and presentations. Develops impact assessments related to Policies and Directives implementation. Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule. Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency. Ensures that all current vendors are qualified and conduct audits of approved Third Party Manufacturers and other 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. Executes the Inspection Readiness Program. Ensures that recall operations are capable of being initiated promptly and at any time. This includes that lists are maintained of customers of all batches distributed and of distribution information. Supports Quality Risk Management. Provides support to Site Projects. Prepares and manages Annual Product Quality Reports Program. Creates, reviews, approves and tracks corrective actions related to internal and external audits. Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations. Verifies BMS and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed. Liaison for regulatory initiatives. Supports product submissions. Manages Licenses renewals. Manages the Records Retention program. Bachelor's Degree in Chemical, Engineering, Biology or Microbiology Science. Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry. Fully Bilingual (Spanish/English) communication skills, both written and verbal are required. Strong knowledge of relevant GMP, FDA, EU regulations. Expert in the interpretation and application of regulations according with the intended use. Self-motivated, creative and team work oriented. Excellent interpersonal skills and the ability to interact with people at all levels. Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses. Self-motivated, creative and team work oriented. Self-starter and good organizing and planning skills. Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise. Strong knowledge and experience in statistical tools. Strong presentation skills. Able to exercise good judgment. Able to work under pressure. Willing to work irregular hours, rotating shifts, weekends and holidays, when necessary. SDL2017
Ciudad: manati
