CMC Quality Associate
CMC Quality Associate
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Salary Not Disclosed
1 Vacancy
Job Description
Industry: Pharmaceutical
Location: Malta
Basis: Full time
Remuneration: Salary Benefits
Main Duties:
- Review data for reports investigations KPIs and other quality indicating metrics and trend analysis
- Maintain appropriate quality oversight of SOPs for operational activities
- Develop procedures and controls in support of the Quality Management System
- Compile assess and report metrics related to quality systems
- Provide ongoing support to the CMC function to ensure delivery of GMP requirements
- Works closely with the CMC Lead and CMC Regulatory on any open CAPAs deviations change control actions or external GMP audit observation follow ups
- Maintain stability programmes on all protocols reports and data is available
- Forward manufacturing batch records and release documents to stakeholders
- Manage complaints and any deviation investigations related to manufacturing activities and Tracks associated Corrective Actions/Preventive Actions
- Follow up on risks raised and associated mitigation action to ensure implementation
- Ensure all manufacturing change controls are captured and followed up within companies quality system
- Participate in GxP Audits as required
- Ensure that QTA obligations are maintained between the company and their thirdparty suppliers
What skills do you need:
- Minimum of 5 years experience with GMP Operational Quality Systems for Commercial Drug Product in a pharmaceutical or other life science organisation
- Experience in utilising of quality System processes (such as Audit Deviations CAPA Risk assessments & Change Control)
- Experience of authoring SOPs reports protocols and other GxP documents
- Detail oriented with ability to research analyse and report independently across a breadth of topics
- Ability to work in a fastpaced environment and under pressure
- Selfstarter with ability to work independently
- Strong written and verbal communication skills
Eligibility to work in the EU is a must
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Employment Type
Full Time
