Quality Assurance Specialist (Quality Agreements)

One of our clients from the pharmaceutical industry is building a new hub in Warsaw and is looking for talented professionals, that would contribute to its success by joining the new team.

We are looking for a Quality Assurance Specialists that would be responsible for preparation, negotiation, and signing of quality contracts between the Company and relevant parties according to current EU-GMP legislation for outsourced activities.

Office location: Warsaw

Hybrid model: 3 days office-based, 2 days home-office

Main responsibilities:

Preparation of Quality Contracts:

• Identify requirements and expectations from both the Company and relevant parties.
• Draft a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party
• Ensure that the draft contract complies with current EU-GMP guidelines as well as internal guidelines.

Negotiation of Quality Contracts:

• Engage in negotiations with the relevant parties to reach mutually acceptable terms.
• Be prepared to discuss and adjust contract terms based on feedback from the relevant parties.
• Work closely with internal stakeholders to ensure that all aspects of the contract are covered.

Signing of Quality Contracts:

• Ensure that all necessary approvals and signatures are obtained from both the Company and the relevant parties.
• Ensure proper documentation and archiving of the signed contracts.

Handling of Change Controls and closure of tasks related to quality contracts.

Requirements:

These tasks require a high level of communication skills, EU-GMP understanding, and the ability to work cross-functionally within the organization. It is also important to have a good understanding of the specific quality requirements applicable within the Company.

• Educational Background: Academic educational background, Master of pharmaceutical science, master of medicinal chemistry, master of science in chemistry, chemical engineer, master in biochemistry, Master of manufacturing engineering.
• Experience: Minimum of years of experience in Quality Assurance or Quality Control. Background in experience in the manufacturing of pharmaceuticals is preferred.
• Communication: Excellent verbal and written communication skills. Ability to effectively communicate complex quality related information to internal and external stakeholders. Experience from communication in international companies is preferred.
• Problem-Solving: Strong analytical and problem-solving skills. Ability to make informed decisions and manage risks.
• Regulatory Understanding: Knowledge of global regulatory requirements and guidelines related to quality incl. EU GMP and EU GDP.

What you'll get in return

• Career in an organization with Scandinavian culture and values: Experience a work environment that emphasizes equality, work-life balance, and sustainability.
• Work in a hybrid model (3 days in the office per week)
• Potential for a permanent contract after an initial 3-month period.
• Comprehensive medical coverage through Medicover.
• Sports Card: Access to various sports facilities and activities.
• Life insurance coverage for added security.
• Opportunity to be involved in the transition of processes.
• Attractive and competitive salary.

Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.