Quality Assurance Specialist

Full Job Description

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

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

The Quality Assurance Specialist will be responsible for ensuring that all production points adhere to strict procedures working under the QA Manager guidelines following the SOP and product tracking.

QA Specialist will be responsible for complying with Good Agricultural and Collection Practices (GACP) and Good Manufacturing Practices (EU-GMP).

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

Key Responsabilities:

• Update and maintain the QMS to ensure compliance with GACP and EU-GMP standards.
• Ensuring that finished product tests are done in accordance with product release specifications.
• Ensuring all testing related to starting materials, in-process materials, bulk materials, packaging materials or any production-related testing done according to specifications.
• Develop and implement sample instructions, test methods and other Quality Assurance procedures.
• Read and interpret all laboratory test results.
• Develop, write, implement and/or review Validation and Qualification protocols.
• Ensure proper calibration, equipment qualification and validations (including test method validations) are performed.
• Train and supervise production employees to implement the procedures (SOP’s) necessary to meet GACP and EU-GMP standards.
• Prepare for and participate in all third-party audits and inspections.
• Ensure strict implementation of SOPs and compliance with quality assurance requirements.
• Carry out physical inspections of the product from seed to sale.
• Ensure that all records and documents are complete and filed in accordance with company policy, GACP and EU-GMP guidelines.
• Keep specification sheets and other relevant documents for all products.
• Develop, and update production practices and sanitation programs, implementing the latest regulatory requirements.
• Guarantee Lot ID traceability procedures from seed to sale.

Skills & Qualifications:

• Higher education in Pharmaceutical Sciences / Pharmacy / Biology/ Biotechnology/ Biochemistry or related areas.
• Good knowledge of Good Manufacturing Practices (EU-GMP) and 1 Years + of relevant experience in pharmaceutical industry.
• Good Agricultural and Collection Practice (GACP) Guidelines is a plus.
• Must be able to read and interpret lab testing results.
• Experience in developing SOPs, work instructions, and drafting technical reports.
• Experience working with suppliers and contract manufacturers.
• Knowledge of general management principles and practices.
• Willing to perform a multitude of tasks in a dynamic work environment.
• Good problem-solving skills.
• Exercising professional judgment and decision making.
• Knowledge of Portuguese national authorities’ regulations (INFARMED) and EU regulations.
• Ability to follow directives issued verbally and in writing.
• Fluent in Portuguese and English.

Preferred Abilities (Plus)

• Driver’s License and personal car is needed.
• Microsoft Office suite skills (word, excel) and ability to learn and use new computer systems.

In short, GREATSOUL is looking for someone that is willing to go that extra mile, always up for a new challenge, who shares our enthusiasm, passion and dedication in this new thriving industry.