NEW
REF 1791664
11 hours ago | Dubai | full time
- General
- Location: Dubai
- Occupancy: full time
- Description
- OVERALL ROLE OBJECTIVE:
To work as part of the Quality Assurance team at Almac Pharma Service’s Ireland facility in
Dundalk, Ireland. The post holder will support the Pharmaceutical Quality System (PQS) and
verify the adherence of manufactured products for human use, in line with current Good
Manufacturing Practice (cGMP).
JOB SPECIFIC RESPONSIBILITIES:
The following is a non-exhaustive list of responsibilities:
1. Utilise a broad understanding of cGMP to provide QA support, mentoring and coaching
for Operations, Analytical, Logistics and Engineering departments to assure that
activities are undertaken in compliance with cGMP and Almac procedures, as
appropriate.
2. Provide quality assurance support/advice to operational departments in support of new
and existing projects and products. This will involve interaction with internal and external
customers to achieve required timelines while maintaining product quality and
compliance.
3. Internal/external contact for queries related to product compliance and quality
4. Play an active part in the development of the Pharmaceutical Quality System (PQS) by
constructively challenging deficiencies and inefficiencies.
5. Collate and review data to be used in reports, investigations, key performance indicators
(KPIs) and other quality indicating metrics.
6. Conduct internal audits as per the approved schedule to detect process and procedural
deficiencies. Support the affected areas to ensure appropriate corrective and preventive
actions (CAPAs) are undertaken to correct any observations.
7. Assist and participate in audits of external suppliers, as well as assist in hosting
customer and regulatory audits as required
8. Participate in the Supplier Management Process to assure that materials are
appropriate for pharmaceutical manufacturing
9. Aid as necessary, the life cycle of PQS documentation, such as Deviations, Change
Controls, Suspect Analytical Results, Risk Assessments, Technical Agreements,
Procedures, Generation, approval and training of new/revised procedures etc.
10. Assist in the compilation and review of Product Quality Reviews/ Annual Product
Reviews, as appropriate
KEY SKILLS Effective:
- communication skills (both written and oral)
-Proficiency in the use of IT applications (Word, Excel,Outlook, Project,PowerPoint etc)
-Excellent attention to
detail
-Proven ability to work effectively on own initiative as well as contributing to the team environment
- Requirements
- QUALIFICATIONS :
- Bachelor’s degree (or equivalent) in a scientific or technical discipline or relevant equivalent experience in a GxP Quality Assurance role
- EXPERIENCE: Worked within a pharmaceutical / GxP environment in a Quality related role Writing and producing scientific reports
- Provisions
- Salary: to be discussed
- Employment visa provided
- Transportation provided
- Housing provided
- Medical insurance provided
- Publisher
- direct employer
- 51 - 200 employees