Country Malta
City Hal Far
Functional Area Operations
Job Group Quality Assurance
Employment Type Permanent Contract
Working time Full-time
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
Position Summary
We are seeking to recruit a Quality Systems Specialist to join our Quality (Systems) Department, reporting directly to the Quality Systems Manager. This position plays a key role in supporting and enhancing our quality systems by focusing primarily on maintaining electronic quality management tools, ensuring regulatory compliance, and contributing to process improvements. The successful candidate will bring strong analytical skills, a detail-oriented mindset, and the ability to collaborate effectively across teams.
The chosen candidate will be responsible for:
· Supporting the development, control, and continuous improvement of quality principles in alignment with the company's internal quality requirements and GMP guidelines (such as cGMP, ICH, 21 CFR).
· Managing and maintaining the company’s documentation system to ensure effective control of quality documents such as SOPs, forms, the Site Master File, analytical methods, and batch records.
· Managing and maintaining the company’s electronic systems, ensuring full compliance with Computer System Validation (CSV) requirements.
· Participating in risk assessments related to ongoing site operations, as required.
· Leading and participating in the Site Internal Audit Program.
· Coordinating and managing client and regulatory audits conducted at the site.
· Overseeing the management of the site's archiving system.
Your profile
· A post-secondary qualification in life sciences or a related field; a degree in life sciences is preferred.
· Previous experience in a pharmaceutical quality systems environment is considered an asset.
· Proficient use of MS Office applications, and familiarity with electronic management systems such as TrackWise and LabWare.
· Excellent interpersonal and communication skills both verbally and in writing
· Strong attention to detail with a proven ability to analyze and troubleshoot problems, identify solutions, and implement effective methods and procedures.
· Strong organizational skills with the ability to manage multiple projects, duties, and assignments simultaneously.
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Hal Far
Hal Far is our drug product manufacturing site for solid dosage forms. It offers innovative and generic drug products for the global market with a competitive cost structure at Swiss quality level.
Main activities
- GMP commercial manufacturing of solid oral pharmaceutical dosage forms
- Supply of tablets, film tablets, and hard capsules filled with powder or pellets, in bulk or blister packed
- cGMP high-potency suite
Features
- 1 –10 μg / m³ segregated cGMP production areas for high-potency
- 7 GMP suites: Dry & wet granulation, Tableting (up to 2 billion unit p.a.), Capsuling (up to 1 billion unit p.a.), Coating (up to 1 billion unit p.a.), Blistering (up to 100 million blisters p.a.)
Strategic importance
- CMO for innovative and generic drug products for the global market
- Competitive cost structure at Swiss quality level