Description
We are seeking a professional with experience in qualification and validation of pharmaceutical packaging equipment and processes to support one of our clients in the pharma sector in developing documented evidence compliant with appropriate requirements and specifications for its intended use and with the current regulatory framework of the pharmaceutical industry.
**RESPONSIBILITIES:**
Preparation of master qualification/validation plans.
Drafting of DQ / IQ / OQ / PQ protocols.
Management and execution of equipment and system qualification activities.
Risk assessment of the process and adherence to planning.
Preparation of reports.
**REQUIREMENTS:**
Engineering degree (Industrial, Mechanical, Electrical or related field).
Minimum 3 years of experience working in GMP environments and in qualification of packaging equipment and processes (blister machines, cartoners, labelers, weighers or similar equipment) within the pharmaceutical industry.
Knowledge of GxP regulations, EMA, FDA and CFR Part 11, as well as other systems, will be considered a strong asset.
Advanced English level: B2/C1 – spoken and written.
Strong technical problem-solving skills and communication abilities.
Rigorous and efficient individual, capable of collaborating effectively within multidisciplinary teams.
**WHAT DO WE OFFER?:**
Joining a stable, high-impact project within the pharmaceutical sector.
Participation in GMP environments involving high-level technical validation and qualification projects.
Integration into a specialized and growing team.
High degree of autonomy and professional development opportunities.
Permanent contract.
Positive work environment and strong corporate culture.
Flexible working hours.
If you believe you meet the profile requested and are interested in this opportunity, please apply without delay. All criteria will be discussed in detail during the interview.
We look forward to meeting you!