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Qc technician microbiology (principado de asturias)

Mcr International
Publicada el 23 enero
Descripción

AH-
QC TECHNICIAN MICROBIOLOGY
ASTURIAS

About the Role

We are looking for a highly skilled and detail-oriented QC Technician - Microbiology to join an important healthcare company. In this role, you will lead and oversee critical laboratory operations, ensuring compliance with GMP standards and regulatory requirements. You will play a key part in maintaining the integrity of the quality systems, driving process automation, and supporting continuous improvement initiatives.

Key Responsibilities

- Ensure compliance with company procedures on Safety, Environment, and Quality.
- Supervise and guide analysts in performing laboratory tests and activities.
- Review and approve analytical documentation, including test results, certificates of analysis, stability studies, and supplier qualifications.
- Collaborate in drafting SOPs, specifications, analytical methods, and stability protocols.
- Manage SAP entries for results, batch management, and material creation.
- Guarantee proper packaging and custody of QC samples (stability, cleaning, reference standards).
- Oversee calibration and qualification of laboratory instruments and maintain related documentation.
- Lead technical services activities: equipment calibration, qualification, and lifecycle management.
- Maintain updated procedures for computerized systems validation and ensure data integrity.
- Manage supplier qualification for services and equipment.
- Evaluate and review data from external laboratories.
- Drive continuous improvement projects and promote process optimization and automation.
- Support production and analytical development activities (method validations, transfers, investigations).
- Collaborate in aseptic process simulation design and execution.
- Provide technical support during audits and inspections by health authorities.
- Assist in preparing responses to technical inquiries from clients and regulatory bodies.
- Contribute to internal training and analyst qualification programs.

Regulatory & Quality Compliance

- Update laboratory procedures to meet GMP and pharmacopeia requirements.
- Review validation protocols and reports to ensure regulatory compliance.
- Participate in risk assessments, deviation investigations, and CAPA implementation.

What They Offer

- A dynamic and collaborative work environment.
- Opportunities for professional growth and involvement in innovation and automation projects.
- Exposure to international standards and interaction with health authorities and integral suppliers.
- Competitive compensation and benefits package.

Qualifications

- Degree in Biology or related field.
- Valuable Microbiology specialization.
- Minimum 1 year of experience in Quality Control within the pharmaceutical industry working specialized in Microbiology.
- Excellent communication, and problem-solving skills.

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