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Senior QA specialist
Росоман
Рок за пријавување:
- Синцеритас АД Скопје
Senior QA specialist
At SINCERITAS, we cultivate and process pharmaceutical-grade cannabis into medicinal products to improve patient health and provide relief. Offering cutting-edge solutions for numerous medical needs, we strive to meet every client’s unique requests by tailor-making each product.
We are a team of experienced science professionals that use industry-standard practices in agricultural and pharmaceutical techniques to manufacture high-quality medicinal cannabis products consistently and reliably. Our products are developed to retain all of the plant’s essential components and ensure a maximum medicinal effect, particularly in patients with rare and difficult-to-treat conditions.
Through ongoing scientific research and development, we aim to unlock the full therapeutic potential of cannabis, opening the doors to new and revolutionary medical treatments.
Sinceritas is made up of talented diverse team of over 60 employees who deliver innovative solutions that add value across a variety of Business Service functions. Our company culture is build on three pillars: Science.Progress.Trust
SINCERITAS offers premium workspace at our facility in Rosoman and administrative office in Skopje.
Provide Quality leadership, direction, and governance for the specific areas of responsibility. Manage quality-related matters specific to area of responsibility. Responsible for approving appropriate quality-related documents. Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices & promptly report any safety concerns. Perform ongoing monitoring that includes - monitoring of quality systems, production area time on floor audits, verification of the effective implementation of key GMP, GACP and ISO programs and review of systems that impact product quality to ensure that they operate in a state of control. Provide QA ownership for products manufactured in area of responsibility.
Provide coaching and mentoring to operations personnel and to other QA representatives on appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion,
Responsibilities
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
- Ensure compliance to GACP, ISO 19001; 14001; 45001; 17025 and GMP,
- Review and approval of QMS documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
- Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
- Evaluation and contribution of regulatory information to regulatory documents Monitoring of GMP compliance, GMP programs including data integrity and systems by ensuring a regular presence the area of responsibility
- Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
- Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
Key attributes
- Excellent attention to detail.
- Experience working in cross functional teams and proven ability in decision making.
- Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
- Strong organizational skills, including ability to follow assignments through to completion.
- Understanding of Data Integrity and its applications
- Self-motivated, positive and ability to work under pressure.
- Demonstrates flexibility and adaptability to meet business needs.
- Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry or related field.
- Advanced degree (master's, doctoral, specialist studies) is considered an advantage.
- Minimum 3 years in quality assurance preferably in pharmaceutical industry
- Excellent knowledge of QMS in the pharmaceutical industry standards
- Self-motivated, detail-oriented, and willing to accept additional responsibilities.
- Good knowledge of written and spoken English.
What we offer:
By investing in new development capabilities, state-of-the-art manufacturing facility, and partnerships we have the opportunity to shape the future of SINCERITAS and give more patients access to affordable, high-quality medicines - sustainably. Our dynamism and entrepreneurial spirit are driven by an open, collaborative culture, supported by our talented and ambitious colleagues who, in return for the use of their skills, experience an agile and collegial environment with impactful, flexible careers in which diversity is welcome and personal development is encouraged!
In addition to a basic salary in line with market, we offer and attractive bonus program, training and further education programs.
Please send your CV using the Apply option.
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