Quality Assurance Services Jr, Technician
hace 2 semanas
J
**OB PURPOSE**:
This position will provide support for and be responsible of a range of Quality Assurance functions.
This position will contribute to ensure the foundations of the Quality System and operation handled in ALK Madrid are aligned to established cGMP to ensure lasting customer satisfaction.
This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.
**MAIN ACTIVITIES**:Perform Quality Assurance activities associated with maintaining the Quality Systems:
- Participate actively in the GMP T**raining System**
- ollaborate in the execution of cGMP-training program.
- rovide the initial mandatory GMP training to new employees.
- articipate in Global Forum regarding the training system and the training tool.
- esponsible of implementation of a quality training mindset.
- Handling of T**echnical Complaints**
- lan and perform investigations regarding potential quality issues reported by the market.
- andle of complaint samples and documentation.
- nsure corrective and preventive actions are implemented.
- **
Documentation System**
- rovide on-site guidance in the preparation of procedures and working instructions
- reparation of SOPs for Quality Assurance Activities
- ontrol documentation
- upport to the Documentation tool
- upport regarding the documentation system and ensure the implementation of good documentation practices.
- Participate in the writing of the A**nnual Product Quality Reviews **reports, corresponding to product manufactured/packaged on site.
- For all QMS sub-systems for which the ownership is assigned:
- nsures alignment of their sub-system with Regulatory expectations and with ALK requirements.
- rovides system overview during audits & inspections.
- ollaborate in the preparation of responses and drives follow up of correction actions from audits (internal and external).
- rovide support to global projects as requested.
- ctive participation in continuous quality improvements initiatives
**CANDIDATE REQUIREMENT**:
Education: University degree in Pharmacy, Chemistry, Biology or equivalent.
Experience: Experience in Quality Assurance activities.
Competence overview:
- ood team player with strong interpersonal skills
- kills to participate in different forum, dealing with a variety of cultures and non-routines matters in stressful situations.
- bility to provide training
- ractical and enquiring approach to problem solving.
- luid communication, both written and spoken in English.
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