СИНЦЕРИТАС АД Скопје лого

Специјалист во осигурување на квалитет

За компанијата:

Синцеритас е фармацевтска компанија основана во 2017 година, специјализирана за производство на производи од медицински канабис. Компанијата е извозно ориентирана, со сопствен производствен капацитет... повеќе за компанијата »

Активни огласи од СИНЦЕРИТАС АД Скопје:

HR Specialist - Head of Quality Assurance - Pharmaceutical Industry

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 100 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.

Job Title: Quality Assurance Specialist

Reports to: Quality Assurance Manager

Company: Sinceritas AD

Department: Quality Assurance

Location: Rosoman

The Quality Assurance Specialist participates in processes aimed at ensuring consistent product quality through the implementation of Good Manufacturing Practice (GMP) systems.


Responsibilities

  • Develops and writes procedures (SOPs) in compliance with Good Manufacturing Practice (GMP);
  • Participates in procedures and activities arising from corrective and preventive actions (CAPA);
  • Prepares the Annual Product Quality Review (APQR);
  • Develops validation protocols;
  • Reviews qualification documentation;
  • Participates in deviation investigations;
  • Performs change control activities;
  • Maintains records of SOPs and conducts periodic reviews;
  • Conducts risk assessments;
  • Performs trend analysis of environmental monitoring results and reviews whether all critical trends are properly addressed;
  • Participates in the management of the raw materials control system;
  • Effectively contributes to implementing accurate root cause analysis to determine underlying causes and ensure continuous improvement;
  • Prepares GMP-related instructions and guidance for other departments;
  • Prepares and reviews product stability studies;
  • Performs other responsibilities related to quality assurance programs and procedures in accordance with the candidate’s skills and qualifications.

Qualifications

  • Minimum of 2 years of work experience in a Quality Assurance department;
  • Bachelor’s degree in one of the following fields:
    • Pharmacy
    • Chemistry
    • Biology
  • Strong ability to maintain a Quality Assurance system, including batch record review and document control, including quality testing documentation;
  • Excellent knowledge of MS Office applications;
  • Strong technical writing skills (SOPs, annual reports, investigation summaries, etc.);
  • Ability to work independently with strong attention to detail;
  • Excellent command of the English language, both written and spoken.

 

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:

1. Organized transport from Skopje to Rosoman

2. Provided meal for all the employees

3. Collective insurance for all the employees

EMPLOYEE LOYALTY & LONG-TERM BENEFITS

Seniority Salary Increase Tiers

Private Health Care Loyalty Incentive

Vacation Voucher Benefit

Additional information: Candidates who meet the above conditions can send their CVs in English via Fast Apply.

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