What are the responsibilities and job description for the QA Specialist position at Siegfried?
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
SUMMARY: The incumbent is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
EDUCATION AND EXPERIENCE:
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 Grafton
The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing services, including services for projects with highly potent APIs.
Competencies
Your role
SUMMARY: The incumbent is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to manufacturing operations. This position’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMPs and internal procedures/policies are maintained, and b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
- Maintain environmental monitoring database and compile trend reports
- Maintain Quality databases including Archival and scanning of cGMP documents and records, Departures, media fill programs, and training files
- Perform real-time batch record review to ensure the executed record may be delivered to Quality Assurance, 100% completed and ready for review
- Represent Siegfried Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
- Solicit feedback from Manufacturing for operational improvement. Liaison with Process Engineering to ensure that Manufacturing feedback is incorporated, where appropriate, into the process design
- Author or revise SOPs
- Perform manufacturing area and labeling clearances as well as inspection of material
- Review and approve CAPAs, Deviations, Change Controls, Equipment Excursion Reports
- Assist in performing investigations
- Perform internal audits and weekly walkthroughs
- Perform QA visual inspection activities associated with clinical and commercial drug product
- With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
- Assist in developing and delivering training
- Assist in tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
- Develop and/or maintain Quality System metrics for management review
EDUCATION AND EXPERIENCE:
- Associates’ degree in related field required
- Bachelors’ degree in life science field
- 3-5 years’ experience in a cGMP FDA-regulated industry
- Strong familiarity with the regulatory requirements of 21CFR210 and 211 or 820
- Excellent written/oral communication skills
- Focused self-starter with attention to details; team-oriented but able to work independently and proactively, and ability to multi-task
- Strong problem solving and organizational skills
- Experience working in a cleanroom with a thorough understanding of cleanroom personnel and material flows a must
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 Grafton
The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing services, including services for projects with highly potent APIs.
Competencies
- Early-phase development and manufacturing
