We are seeking to employ a Pharmaceutical Technology Officer - Process for our manufacturing site in Malta.
Within the company, the Pharmaceutical Technology Officer - Process is responsible for supporting activities linked to introduction of pharmaceutical products within the manufacturing facility from the feasibility studies up until conclusion of process validation. The Pharmaceutical Technology Officer - Process also takes an active role in ensuring that all validation activities are carried out in a timely manner; in accordance with the Pre-established Program and Validation Master Plan under the direction of the Pharmaceutical Technology Specialist - Process. This must be achieved through efficiently both in time and material resources, while ensuring compliance with GMP, company procedures, as well as Pharmacopoeia standards. The Pharmaceutical Technology Officer - Process also supports all aspects of improvements of manufacturing processes such as scale-ups, process optimization and validation of alternate suppliers and ensures that these projects are completed in the according pre-established time schedule.
Role & Responsibilities:
- To support the Pharmaceutical Technology Specialist – Process in the coordination of Pharmaceutical Technology projects (study, design, evaluate, conclude, implement, control and follow-up) and ensure that projects are completed in time according to the pre-established time schedule.
- To liaise with the relevant departments, as necessary, to ensure information is disseminated and co-ordination of activities across the site is achieved to ensure projects are completed on time.
- To aid in issuing, check and approve of all Submission, Process Optimization, Validation and Cleaning Validation documents, in accordance with company and GMP standards.
- To actively assist and follow-up on any investigations which might arise during manufacturing and testing of submission, optimization and validation batches.
- To assist in the issuing of manufacturing methods in accordance with the requirements defined within the Product Registration Dossiers and filings.
- To support all aspects of manufacturing process transfers for individual products.
- To ensure that all transfer activities are successfully concluded in time for product submission, product launch or any regulatory requirements.
- To support technical and scientific investigations into manufacturing and product related issues and to assist Production and Quality with troubleshooting related to formulation, process related difficulties and validation issues.
- To implement and make use of a Risk Management Process for Process Optimization, Process Validation and Cleaning Validation
Qualifications, Experience & Skills
- A first degree in a science background or several years’ experience in a manufacturing environment in the Pharma industry or related business.
- Ideally 1-2 years’ experience in manufacturing of solid oral doses
- A good understanding of production processes and formulations
- Possess a pro-active, dynamic and flexible approach
- Have excellent interpersonal skills
- Have excellent communication skills (verbal and written)
- Good management skills
- Ability to coach, supervise and lead the team
- Problem solving approach, organized & flexible
- Possession of communication, trouble-shooting, and function skills.
- Proactive attitude towards work and learning new techniques.
- Ability to understand and work towards the company vision and strategy
Please send your CV to: firstname.lastname@example.org