Responsible Person / Quality Systems Snr Specialist

Siegfried

Malta Island
Permanent
Full-time

1 month ago

General InformationCountry MaltaCity Hal FarFunctional Area OperationsJob Group Quality AssuranceEmployment Type Permanent ContractWorking time Full-timeAt 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

Performing a pivotal interface for client and authority inspections, preparedness, readiness and post-audit follow-ups;
Ensure appropriate distribution practices to safeguard product users, including compliance with GDP regulations and best practices in all regulated activities. Additionally, maintain a compliant quality system, including a document control system, to ensure adequate record management;
Leading and supporting action plans and risk assessments concerning any potential nitrosamine contamination in various products;
Representing the Quality Systems in Project Leadership Teams on new product introduction;
Performing and managing RP duties for any controlled drugs on site.

Your profile

A tertiary level of education in life sciences or a related field, with preference given to candidates holding a pharmacy degree;
Preferably with 2-3 years of previous related experience in quality and/or systems within the pharmaceutical sector;
Attention to detail is crucial, and the ability to work both independently and as part of a team.

Working at SiegfriedSiegfried'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 areIn the Midst of People's Lives - Across the GlobeThe 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 FarHal 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

Siegfried

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