Quality Assurance Manager - Sin especificar, España - Chemo

Descripción

Insud Pharma is a recognized and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialized in the research, development, manufacturing and commercialization of active pharmaceutical ingredients and medicines for human and veterinary use.

Chemo, an industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 drugs with more than 200 different product presentations.

Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).Global ResponsabilityCoordinate the implementation and 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, quality control, sterility and all related process of the pharmaceutical products to assure Quality and Compliance.

Responsible for implementing procedures for inspecting, testing, and evaluating the quality of products in accordance with the company's standards.

During the preparation of reports, collect data regarding inspections or other aspects such as the cleanliness and readiness of the production lines and aseptic process, which are then analyzed in detail.

To convey the findings to the area managers and corporate leadership. Assure employees should receive quality assurance training for all aspects of the production process.

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.

Specific Responsabilities

• Coordinate and organize the work of the staff under your charge.
• Supervise and monitor the release of product batches.
• 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 development and approval of quality agreements with customers, suppliers, and contractors.
• 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.
• Train new hires in specific job activities and functions.

Competencies/Career Level 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, initiativeJob requirements/personal skills

Education:
Bachelor's or Master's degree in Pharmacy or Chemical Sciences. MBA desirable.

Languages:
Spanish and English.

• Experience (years/area): +10 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.
COMMITMENT TO EQUAL OPPORTUNITIESLaboratorios Leon Farma / Farmalan is committed to equal opportunities.

We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.