QA Validation and Qualification engineer

GREATSOUL PHARMA – PORTUGAL is seeking an experienced Quality Assurance Validation and Qualification Engineer to oversee and interact with Medical Cannabis plant production and manufacturing procedures.

This role will ensure production of high quality cannabis for Medical markets.

This individual will be responsible for designing validation and qualification protocols and associated documents and (i.e. process validation, cleaning validation, computer system validation, method validation/transfer, and equipment lifecycle documentation).

This is a full time (40 hour per week) position, hybrid, and we need someone who can wear a variety of different hats. We will be producing top shelf, craft cannabis for medical use only.

Main responsibilities:

• Provide QA oversight of commissioning, qualification, and validation activities to GACP / GMP manufacturing facility.
• Design and/or review and/or approve validation and qualification protocols, including related records to certify compliance with specifications and procedures.
• Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, and computerized systems.
• Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computerized system validation.

Job Position Requirements and Qualifications:

• Minimum of 2+ years of Quality Control/Assurance/Validation experience in the biotechnology or pharmaceutical industries.
• Experience in IT systems, automation, operations, and/or manufacturing within the biotechnology industry – new manufacturing facility start-up environments is preferred.
• Must have demonstrated understanding of cGMP.
• Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.
• Proven ability to manage projects while meeting all deliverables and timelines.
• Strong knowledge of regulatory requirements for validation, including GMP, ICH guidelines and Ph. Eur. – GAMP 5 working experience is preferred.

Education:

Bachelor’s degree in science field.