- Supporting the development, control, improvement of the quality principle of the companies national and international GMP Guidelines (e.g. cGMP, ICH, PIC-GMP, 21CFR) and internal quality requirements within the Site Malta.
- Interacting regularly with professional colleagues in all function groups to be updated, and to understand their current contribution and impact upon quality.
- Ensuring that complaints are registered, investigated and approved . Establish an appropriate reporting tool or ensures that systems defined by global corporate are applied and reporting is performed as predefined
- Ensuring that the following tasks are managed within the team "Quality Systems":
- Change Control Management
- SOP and training Management
- Documentation Management
- Leads external/internal audits and health authorities inspections
- Customer questionnaires and selfassessments
- Leading the overall process of planning of internal audits
- Preparation of different quality statements
- Supplier/Vendor qualification
- Pest control
- Maintenance of the SMF
- TrackWise Management
- The management and execution of various projects within Siegfried Malta
- CAPA Management
- CSV Validation Skillsets and Requirements
- Currently based in Malta
- Fluency in English Education & Experience
- Hold a tertiary degree level of education in a related field, and at least 5 years' experience in the Pharmaceutical industry with significant experience working within a pharmaceutical quality system;
- Having a QP Status or eligible to be a QP is considered an asset;
- Possess the right attributes in leading a team, having strong interpersonal and communication skills;
- Analysing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution
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Quality Systems Manager - Malta Island - Konnekt
Description
A new role as a Quality Systems Manager within the Pharmaceutical industry is now available.Reporting to the Head of QA, your responsibilities will include:
Job Reference:
IJ837
Primary job focus
Quality Control
Job type
Full Time
Employment level
Experienced (3 years +)
Employer industry
Healthcare
Languages
English
