Validations technician

Found in: Resume Library US A2 - 2 weeks ago

Ambler Pennsylvania, United States INSUD PHARMA, S.L.U. Full time
Overview:
Maintain the validation status of the processes related to the manufacture of injectable products (manufacturing processes, aseptic process, cleaning, conditioning, etc.).

Responsabilidades específicas

Collaborate in the documentary development (protocols and reports) and in the execution of the tests required for the valition of processes (formulation, filling, conditioning, etc.) in order to prepare the documentation of validation associated to the manufacturing and cleaning processes.

Develop protocols and reports and execute the necessary tests for the validation of the manufacturing processes.

Develop protocols and reports and execute the necessary tests for the cleaning validation.

Develop protocols and reports for the validation of the aseptic process (media fill). Participate in the execution of the aseptic process validation.

Review protocols and validation reports performed by internal or external personnel ensuring proper execution and performance of activities.

Participate as an expert in external audits and inspections.

Maintain the archive of validation documentation.

Management of quality systems (deviations, change control, CAPA plans…) associated with specific validation tasks.

Train the new incorporations in the specific activities and functions of the position in which you are an expert.

Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self-development, integrity, analytical and decision-making skills, sense of urgency, initiative.

 

Requirements and personal skills

Education: University degree in Pharmacy, Chemistry, Chemical Engineering, or similar.

Languages: Spanish and English.

Experience (years/area): 3-4 years in the Validations, Technical Services, Quality Assurance or Production Department of a pharmaceutical plant, preferably in a manufacturing plant for injectables.

Specific knowledge: GMP (EU and FDA).

Travels: Not required.

Personal skills: good communication skills, proactivity, good work under pressure, teamwork, problem solving, good organizational skills and persistence.

Responsibilities:
Maintain the validation status of the processes related to the manufacture of injectable products (manufacturing processes, aseptic process, cleaning, conditioning, etc.).

Responsabilidades específicas

Collaborate in the documentary development (protocols and reports) and in the execution of the tests required for the valition of processes (formulation, filling, conditioning, etc.) in order to prepare the documentation of validation associated to the manufacturing and cleaning processes.

Develop protocols and reports and execute the necessary tests for the validation of the manufacturing processes.

Develop protocols and reports and execute the necessary tests for the cleaning validation.

Develop protocols and reports for the validation of the aseptic process (media fill). Participate in the execution of the aseptic process validation.

Review protocols and validation reports performed by internal or external personnel ensuring proper execution and performance of activities.

Participate as an expert in external audits and inspections.

Maintain the archive of validation documentation.

Management of quality systems (deviations, change control, CAPA plans…) associated with specific validation tasks.

Train the new incorporations in the specific activities and functions of the position in which you are an expert.

Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self-development, integrity, analytical and decision-making skills, sense of urgency, initiative.

 

Requirements and personal skills

Education: University degree in Pharmacy, Chemistry, Chemical Engineering, or similar.

Languages: Spanish and English.

Experience (years/area): 3-4 years in the Validations, Technical Services, Quality Assurance or Production Department of a pharmaceutical plant, preferably in a manufacturing plant for injectables.

Specific knowledge: GMP (EU and FDA).

Travels: Not required.

Personal skills: good communication skills, proactivity, good work under pressure, teamwork, problem solving, good organizational skills and persistence.

Qualifications:
Maintain the validation status of the processes related to the manufacture of injectable products (manufacturing processes, aseptic process, cleaning, conditioning, etc.).

Responsabilidades específicas

Collaborate in the documentary development (protocols and reports) and in the execution of the tests required for the valition of processes (formulation, filling, conditioning, etc.) in order to prepare the documentation of validation associated to the manufacturing and cleaning processes.

Develop protocols and reports and execute the necessary tests for the validation of the manufacturing processes.

Develop protocols and reports and execute the necessary tests for the cleaning validation.

Develop protocols and reports for the validation of the aseptic process (media fill). Participate in the execution of the aseptic process validation.

Review protocols and validation reports performed by internal or external personnel ensuring proper execution and performance of activities.

Participate as an expert in external audits and inspections.

Maintain the archive of validation documentation.

Management of quality systems (deviations, change control, CAPA plans…) associated with specific validation tasks.

Train the new incorporations in the specific activities and functions of the position in which you are an expert.

Innovation, customer orientation, communication, teamwork, adaptability/flexibility, productivity, self-development, integrity, analytical and decision-making skills, sense of urgency, initiative.

 

Requirements and personal skills

Education: University degree in Pharmacy, Chemistry, Chemical Engineering, or similar.

Languages: Spanish and English.

Experience (years/area): 3-4 years in the Validations, Technical Services, Quality Assurance or Production Department of a pharmaceutical plant, preferably in a manufacturing plant for injectables.

Specific knowledge: GMP (EU and FDA).

Travels: Not required.

Personal skills: good communication skills, proactivity, good work under pressure, teamwork, problem solving, good organizational skills and persistence.

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