Quality Assurance Specialist - Injectable

Nombre de la empresaPQE Group Ubicación de la empresa Santo Domingo, Distretto Nazionale, Repubblica Dominicana

PQE is a service provider company, leader in Pharmaceutical and Medical Device sectors since 1998. With a network of hundreds dedicated consultants, PQE delivers the highest level of expertise to more than 160 customers worldwide. 

An international group, PQE operates in over forty countries throughout Europe, Asia and the Americas. PQE offers a worldwide coverage with offices and representatives across Europe, Asia, the Middle East and Latin America, in order to better serve these specific local markets.

Further information can be found at www.pqegroup.com or visit our company page on LinkedIn https://www.linkedin.com/company/84095

Due to a constant growth, we are currently looking for a Quality Assurance Specialist with experience in the Injectable area.

Responsibilities

• Maintain oversight of the QA program and Quality Management System (QMS) at a single SOFIE manufacturing facility producing products under both 21 CFR Part 212 and 211 (as needed) regulations.
• Apply quality assurance processes and procedures at the site level to ensure product quality and regulatory compliance.
• Write, review, approve, and implement procedures, specifications, processes, and methods as required.
• Oversee the examination and evaluation of each lot of incoming material before use to ensure that the material meets its established specifications.
• Ensure that components, containers, closures, in-process materials, packaging materials, labeling, and finished dosage forms are examined and approved or rejected to ensure that all these meet their current specifications.
• Conduct periodic audits of the site to monitor compliance with established procedures and practices. May infrequently audit another site.
• Liaise with internal and external inspectors and representatives, particularly on QA-related topics.
• Ensure manufacturing and analytical equipment is appropriately maintained and calibrated. Ensure applicable facility certifications are maintained. Identify to management problems in personnel, equipment, and the facility that require correction.
• Review documents associated with the site’s QA program for completeness, errors, and omissions. Review executed CGMP records and product batch records to ensure compliance and product quality.
• Conduct continuous review of aseptic operations to ensure compliance to internal procedures (e.g. gowning, cleaning, sanitation, sterility, environmental monitoring, etc.) and USP/FDA regulations.
• Ensure an investigation is performed and documented when required, and corrective and preventative actions are taken (i.e. follow and maintain corporate CAPA, deviation, and OOS protocols).
• Ensure product complaints are handled in a manner consistent with Company SOPs and FDA regulations.
• Oversee the site-level change control process. Ensure that changes in the laboratory are accepted or rejected as appropriate, and ensure the changes are appropriately documented.
• Attend quality and operational meetings. Interface with Corporate QA and Operations on quality related issues. Provide status updates as required management.
• Other responsibilities as required.

Qualifications

• Technical Degree
• Experience and/or full knowledge of manufacturing operations, preparation of sterile injectables, aseptic processing, and distribution of aseptic products preferred.
• Knowledge of USP, FDA, and cGMP regulations preferred.
• Knowledge of how and ability to write, review, and revise SOPs required.
• Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.
• Ability to write reports, business correspondence, and procedure manuals required.
• Ability to effectively present information, deliver training, and respond to questions from groups of managers, clients, customers, and the general public required.
• Ability to define problems, collect data, establish facts and draw valid conclusions required.
• Proficient in MS Office applications required.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.

Location: Dominican Republic

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