Production Expert III
Lancesoft Europe
Description:
Start ASAP
Duration: 3 Months from Start
Teva Grade: 12 Monthly Salary between 5062 - 6327
PESV screening required
To evaluate and contribute to the realization of pharmaceutical production in accordance with the guidelines established by the Operations Business Unit.
Duties and Responsibilities:
1. Responsible for quality assurance within production, including:
Ensuring the improvement, support, assessment, and control of activities related to pharmaceutical production (bulk manufacturing and packaging).
Key Activities:
- Supporting production with deviations and quality-related issues.
- Assessing and deciding whether production activities should be halted as a result of a deviation.
- Making proposals to improve production methods and products, and implementing developments in production technology.
2. Providing content-related and technical support to the Business Unit regarding quality issues and improvement initiatives.
Key Activities:
- Monitoring and reporting on production processes and any deviations from established procedures.
- Investigating and documenting identified deviations and complaints.
- Performing and documenting root cause investigations and CAPAs (Corrective and Preventive Actions).
- Developing, initiating, and implementing improvement proposals resulting from production deviations, internal and external audit observations, or as part of continuous improvement initiatives.
- Making recommendations regarding occupational health and safety, product safety, and environmental matters.
- Participating in various projects aimed at improving quality-related aspects.
- Supporting compliance investigations and audit responses.
3. Implementing and maintaining company quality standards and GMP instructions, and ensuring adequate documentation and protocol compliance.
Key Activities:
- Reviewing SOPs, production and validation protocols, batch manufacturing records (BMRs), and related documentation.
- Participating in and contributing to projects, change controls, CAPAs, and similar initiatives.
- Providing knowledge transfer and delivering training.
4. Participating in the Business Unit consultation and meeting structures.
Internal Contacts:
- Head of Production
- Shift Managers
- (Basic) Operators and Specialists
- Technicians
- Qualified Persons (QPs)
- QA Employees
- Process Team Leads
- Senior Project Professionals
External Contacts:
As required by functional necessity.
Education Level:
- Academic working and thinking level (Master's degree level or equivalent).
- Preferably in Pharmacy, Chemical Engineering, or a related field.
Knowledge and Experience:
- Knowledge of (aseptic) pharmaceutical processes.
- Knowledge of production control systems.
- Knowledge of quality assurance systems.
- Experience within the pharmaceutical industry in a production environment.
Skills:
- Communication skills.
- Advisory and consultative skills.
- Proficiency in spoken and written English.
- Analytical skills.
- Planning and organizational skills.
- Writing and reporting skills.
- Ability to perform effectively in a dynamic and demanding environment.
- Knowledge transfer and training skills.
Competencies / Attitude:
- Results-oriented.
- Understanding of causes and consequences.
- Team player.
- Technical/professional expertise.
- Collaboration and influencing skills.
- Quality-oriented mindset.
No
Is this an IT position?
Additional Details
- Manager's Requested Bill Rate : (No Value)
- Shore Options Available for this Position : Onshore Only
- Critical Position? : No
- Is this an IT position? : No
- Does the position allow for the worker to be virtual/remote? : No
- Shift Type : Standard Business Hours
- NL Shift Type : NA
- Overtime Applicable? : No
- White/ Blue Collar Worker? : White Collar
- Project Code : (No Value)
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