Overview:
Coordinate the maintenance of the quality system in accordance with Good Manufacturing Practices and in particular with the Manufacturing of Sterile Products. General supervision of the manufacturing process, aseptic practices, sterility and all related process of the pharmaceutical products to assure Quality and Compliance. Organize meetings with production and general management to monitor practices are followed by the business, and assure that all non-conformities, such as sterility test failures, environmental monitoring excursions or deviations from established procedures are investigated to determine the potential impact upon process and product quality and assure CAPA implementation. Responsible for the readiness plans of any GMP inspectio according EUR/FDA requirements as well as according other specific GMP requirements where applicable
**Responsibilities**:
- Coordinate and organize the work of the staff under your charge.
- Coordinate the resolution of deviations, customer complaints, etc., ensuring that they are investigated, their impact is evaluated, and appropriate corrective/preventive actions are established.
- Coordinate the review and approval of documentation (procedures, specifications, analytical methods, deviations, out-of-specification results, change control, CAPA, risk analysis, batch documentation, validations, etc.).
- Coordinate the preparation of the plant before an inspection or audit (Regulatory Agencies and/or customers).
- Attend inspections/audits and respond to deficiencies found within the required timeframe.
- Ensure that Quality System documentation (procedures, deviations, change controls, quality reports, etc.) complies with applicable quality standards.
- Conduct audits and self-inspections in different areas of the plant (quality control, production, warehouse, engineering, and maintenance) according to an established plan.
- Coordinate supplier and contractor audits.
- Supervise compliance with the validation and calibration plan.
- Monitor customer requests related to quality and gather necessary information to respond to such requests.
- Approval of supplier and contractor listings.
- Supervise departmental staff training.
- Coordinate the annual training plan in Good Manufacturing Practices with Human Resources.
- Collection and reporting of quality metrics results applicable to the department.
Qualifications:
Should possess management skills and manufacturing of sterile process experience.
Should be diligent in the work, excellent in organizing and managing meetings, and have leadership qualities.
Innovation, customer orientation, communication, teamwork, adaptability, flexibility, integrity, productivity, self-development, sense of urgency, initiative
**Education**: Bachelor's or Master's degree in Pharmacy or Chemical Sciences. MBA desirable.
- ** Languages**: Spanish and English.
- ** Experience (years/area)**: +5 years in a quality assurance department in a pharmaceutical production plant. Experience in team management and leadership of the quality assurance department.
- ** Specific knowledge**: GMP (EU and FDA).
- ** Travel**: No.
- ** Personal skills**: precision, attention to detail, good communication and interpersonal skills.