Summary:Accountable for providing Humacao site operations with the appropriate service and advice to assure that site quality systems are in place for regulatory compliance and as part of a multidisciplinary team accountable of ensuring the site complies with all laws and regulations established by the Puerto Rico Department of Health and other entities that regulate the manufacturing, packaging, distribution and delivery of solid dosage products. Incumbent must assure that quality systems and programs such as internal audits, annual product reviews, stability, procedures, change controls, gap analysis, complaints, and other are in compliance with GMP regulations. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required by the job function.Responibilities:1. Ensures the site is in compliance will all regulations established by the Department of Health and/or other regulatory entities that regulate the manufacturing, packaging, distribution and delivery of related products.2. Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site.3. Manages the different quality systems and programs established at the site such as but not limited to Change Control, Packaging change controls, Stability, Policies and Directives, Gap Analysis, Customer Complaints, TrackWise System, Site Gatekeeper, Internal Audits, External Audits, Quality Agreements, Supplier Qualifications, Document Control, External Audits, Annual Product Quality Review, and others as assigned.4. Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines.5. Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, Protocols, CAPA, and process deviation investigations and maintains documents in an organized and traceable manner.6. Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance.7. Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits.8. Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required.9.Provides advice and service to all operating departments to assure compliance with cGMP's and other regulations. Investigates customer complaints, issues the corresponding reports indicating possible root cause and recommending solutions.10. Performs formal internal audits and pre-approval inspections at manufacturing, laboratory, utilities, and warehouse operations for cGMP's compliance.11. Prepares reports and follow up on observed deficiencies on a regular basis. Ensures 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.12. Reviews and approves internal and external Quality Agreements.13. Compiles, analyzes site quality compliance metrics (Quality Events, CAPAs, Change Controls, and Inspections results etc.) and prepares metrics presentation to ensure timely identification of trends and recommends action plans to improve performance and present s to the site Quality CouncilIncumbent must possess the capability to evaluate, recommend and make firm decisions on materials, documents, and product final disposition regarding implementation of regulations and quality systems Incumbent will have the authority to take judgment on production activities as result of deviations to cGMP's and/or established policies, directives, and procedures after previous consultation with the site QC/QA Director.The incumbent must assure the compliance with corporate and governmental regulations through a system of documentation matters, investigational audits and inspections.The incumbent must maintain himself/herself updated on the current regulatory and industry trends pertaining to compliance and validations particularly associated to process/products, cleaning, water systems, filtration systems, HVAC systems, filing, changes management, national standards and others. Must promptly react to revise the plant programs to comply with evolving regulatory and BMS requirements.Work independently and with minimum supervision but under established procedures and government regulatory agencies.Interact with the internal site groups, QC/QA, Manufacturing at all levels, to provide necessary support or advice. Must also interact with external groups, such as intercompany divisions and outside companies to which we give or receive services and support (Corporate regulatory affairs groups, compliance groups, etc.)Must interact with governmental agencies, especially in the regulatory field, such as Food and Drug Administration.KNOWLEDGE / SKILL Pharmacist Doctor degree with the Licensed Pharmacist registered in the books of the Puerto Rico Department of Health Minimum Five (5) years experience in the pharmaceutical industry for oral dosage manufacturing or, as a Drug Pharmacist in a Retail Pharmacy Industry Broad knowledge of cGMP governmental regulations and guidelines and ability to interpret and apply them Ability to communicate effectively with wide range of personnel, written and verbal Fully bilingual (Spanish/English) writing and fluent speaking Solid technical writing and interpretation skills related to investigations, process & equipment validations/qualifications, computer system validations, Regulatory Filings, and customer complaints Ability to create / organize cGMP systems and procedures based on regulatory compliance requirements Broad knowledge to conduct and lead GMP Audits (internal and external) and regulatory inspections Leadership skills to handle compliance situations Computer skills (require using computerized systems) Handle multiple tasks and comply with agreed or established completion due dates Willing to work long working hours based on the business needs
