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- Responsible for leading and directing Quality staff including managing their performance and supporting their development.
- Manage resource planning (e.g. shift roster, holidays) per business need
- Responsible for achieving Plant QA Key Performance Indicators
- Provide real-time QA oversight and support for production operations.
- Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs.
- Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, Maximo)
- Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
- Alerts senior management of quality, compliance, supply and safety risks
- Support and represent Quality during audits and inspections
- Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within plant QA, and drive together with production management reduction of repeating events within plant QA and production.
- Provides training and advice to staff in order for them to perform their desired functions.
- Execute batch disposition
- Decision in approval worked hours for contingent workers, holidays
- Decision related to MAP process
- Decision as Qualified Person as laid out in EU Directive 2001/83/EC
- QA batch review and issue resolution (e.g. exceptions, NCs) to enable batch release within agreed timelines.
- Batch Disposition within agreed timelines
- Documentation, NC, CAPA, review and approval within agreed timelines
Qualifications : The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
- Thorough knowledge of the processes involved in clinical and commercial manufacturing.
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person).
- Master’s degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or equivalent
- Typically 2+ years of related professional experience
- Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
- Relevant experience in dealing with Non Conformances and Change Control records
Skills and personality
- 3 years of professional experience in pharmaceutical environment (GMP)
- 1 year managerial experience
- Customer oriented and service minded
- Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
- Good problem solving skills
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Thorough decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.
- Decision quality
- Problem solving – making complex decisions
- Compliance rule-following attitude with high degree of attention to detail.
minimum 3 years
Pharmaceutical Packaging Industry
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