Accountable of manage the Microbiology laboratory testing of all In process samples (parenteral), routine and stability finished products (parenteral and orals), raw materials and filling/packaging components to assure that are in compliance with Bristol-Myers Squibb Co. specifications and with Local, Federal and International regulations. In addition accountable for method qualification/validation and method transfer as applicable. Manages effectively and within operational budget goals the microbiology laboratory to support all manufacturing activities at the Manatí site. This position must comply with all Security Guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Manages the microbiology laboratories functions and gives release to all routine and stability finished products (parenteral and oral), raw materials, filling components, within an established lead period and complying with all Bristol-Myers Squibb Co. and governmental microbiology and sterility, BET , and PM specifications. In addition lead the identification of isolates microorganisms associated with finished products, raw materials, water, gases, and EM. Performs the qualification/validation of microbiology methods for raw materials, and finished products for the corresponding methods such as BET, Sterility and Particle Matter Test. Supervises the qualification of all the microbiology sterilizing and testing equipment. Approves and recommends the necessary Capital Appropriation Request (CARs) and controls the purchase of materials, reagents, culture media and sophisticated systems and instruments for all microbiology analyses. Prepares and maintains the budget for the microbiology section with the appropriate support from subordinates and within established guidelines. Assures that all QC personnel are qualified and trained in the applicable procedure required for their jobs functions and; promotes and maintains good employee relations, teamwork and communication. Schedules and coordinates technical and business skills training for all the Microbiology Section personnel. Interviews, evaluates and selects qualified personnel in compliance with EEO/AA regulations. Enforces Environmental Health and Safety Programs in compliance with Bristol-Myers Squibb Co., Safety Policies, cGMP, GLP, OSHA and Regulatory Agencies as FDA, UK, TESD and others. Ensures that deviations from procedures and specifications applicable to raw materials , components , and finished products are investigated, resolved and documented, that corrective/preventive actions are identified and implemented to avoid the occurrence/recurrence of deviations and that no materials are released before the completion of the investigation. Leads recalls, market withdrawals, and other regulatory actions when authorized by the Sr. Vice President Worldwide Quality & Compliance or as required by local regulatory agencies. Participates in Regulatory inspections and ensures compliance with the marketing authorization requirements. Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Assures that all departments have knowledge regarding the roles, responsibilities and authority of the Microbiology Unit. Assures that the QC equipment and personnel are formally qualified before release testing of products/materials is performed. Ensures that stability data supports the retest/expiry date and storage conditions of the product and that a system is in place to assure trending of data for any anomalies. Verifies consistency with other site procedures and/or specifications. Reviews and approves all laboratory testing records associated to testing of raw materials and finished products before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated. Supports the Lessons Learn and Process Knowledge Programs. Approves or reject functional area procedures impacting drug products, raw material or packaging components. Participates as quality representative or liaison in site projects. Supports product and method transfer initiatives. Prepares and manages functional area Annual Product Quality Reports Program. Supports Process/Manufacturing decisions during audits with regulatory agencies. Reviews and approves investigations related to process, products, microbiology laboratory and calibrations. Ensures that the functional area has effective systems for the maintenance and calibration of critical equipment and approves calibration requests. Ensures appropriate use of laboratory information management systems (LIMS) are in place. B.S. Degree in Biology, Biotechnology, Industrial Microbiology or Microbiology. Ten (10) years of experience of experience in a pharmaceutical industry, and at least six (6) years of experience in a supervisory or managerial role. Knowledge and experience in the following: Parenteral and Oral products; aseptic, non- aseptic, and controlled areas, FDA and cGMP Regulations, sterility testing and sterilization process, BET, Particle Matter test, Microbial Limits test, Bioburden test, microbiology method qualification /validations and Identification of microorganisms by DNA sequence. Administrative ability to handle cost reduction programs, budget preparation, record keeping and related paperwork/reports and personnel training. Bilingual (Spanish / English) oral and written. Knowledge in Environmental, Health and Safety matters as it relates to the site' operations. Strong interpersonal skills are required as well as the ability to motivate people, possess a strong team orientation. Must possess strong organizational skills and be able to develop personnel. Strong analytical skills are necessary. Willing to work irregular hours, rotating shifts, weekends and holidays. SDL2017
Ciudad: manati
