Remedica is a globally active EU-based pharmaceutical company, headquartered in Cyprus and present in more than 110 countries. Founded in 1980, the company has evolved into a trusted generics CDMO and dossier development partner for pharmaceutical companies worldwide. Remedica combines development expertise, EU-based manufacturing capabilities, regulatory know-how and a strong quality culture to deliver competitive, high-quality medicines. Its portfolio includes over 300 products across key therapeutic areas, including cardiovascular, oncology, anti-diabetic, anti-infective, central nervous system, alimentary tract, genito-urinary and musculoskeletal treatments.
Over the last few years, Remedica went through a massive transformational program from a locally recognised reputable company to a global player, respected by its distributors, partners, and clients. The investments into the factories, R&D equipment, new facilities, implementation of best-in-class software, and people development are the baselines for Remedica's success in the future.
Job Purpose:
The purpose of this position is to provide routine Quality Assurance oversight within manufacturing and packaging operations to ensure compliance with Good Manufacturing Practices (GMP), data integrity principles, and company procedures.
The role supports the execution of shopfloor quality activities through regular monitoring of manufacturing operations, timely identification of compliance issues, and collaboration with Production and other Quality functions. The position contributes to maintaining inspection readiness while developing technical expertise under the guidance of senior QA personnel
Duties & Responsibilities:
- Active Shopfloor Oversight
- Maintain continuous and visible QA presence within manufacturing and packaging areas.
- Provide real-time oversight of operations.
- Independently assess compliance of production activities with GMP requirements.
- Act as a key QA representative within operational areas.
2. Rotational Oversight Across Production Areas
- Perform systematic rotation across production suites to ensure comprehensive QA coverage.
- Monitor all stages of manufacturing, including dispensing, granulation, compression, coating, and packaging.
- Ensure consistent application of GMP standards across all production areas.
- Real-Time GMP Compliance Monitoring
- Perform in-depth QA oversight of:
- Line clearance activities
- Batch manufacturing and packaging operations
- Adherence to SOPs and GMP requirements
- Identify, assess, and document deviations, non-compliance, and risks.
- Initiate and support immediate corrective actions in collaboration with Production and QA teams.
- Escalate critical issues to QA management where required.
- Data Integrity Oversight (ALCOA+)
- Ensure compliance with ALCOA+ principles in all shopfloor documentation practices.
- Review batch records, logbooks, and real-time entries for accuracy and completeness.
- Identify and address data integrity risks, ensuring timely correction and escalation.
- Risk Identification & Decision Support
- Apply risk-based thinking to identify potential quality and compliance issues.
- Provide on-the-spot guidance to production teams to prevent deviations.
- Support QA decision-making through timely and accurate reporting of observations.
- Cross-Functional Collaboration
- Work closely with Production, Quality Control, and Engineering teams to ensure compliant execution of operations.
- Provide expert guidance on GMP and documentation practices.
- Maintain QA independence while fostering a collaborative and solution-oriented environment.
- Reporting & Documentation
- Prepare structured daily reports including:
- Scope of Activities
· Areas visited
· Personnel engaged
· Products and batch numbers observed
· Manufacturing steps reviewed
- Observations
· GMP compliance findings
· Data integrity observations
· Identified risks or deviations
- Actions Taken
· Immediate corrections implemented
· Escalations and follow-up actions
- Inspection Readiness
· Ensure reports are clear, detailed, and suitable for regulatory inspections (e.g., FDA, EMA).
- Continuous Improvement & Audit Readiness
- Identify recurring issues and support root cause analysis and CAPA activities.
- Contribute to continuous improvement initiatives related to GMP compliance.
- Support maintaining a constant state of inspection readiness within manufacturing operations.
- Training & Knowledge Sharing
- Provide on-the-floor coaching and guidance to production personnel on GMP and data integrity.
- Support training initiatives to strengthen compliance awareness across the shopfloor.
Qualifications and Skills:
- Bachelor’s degree in Pharmacy, Chemistry, Biology or related Life Sciences field is required.
- Minimum 1–3 years of experience within a GMP-regulated pharmaceutical manufacturing environment.
- Eperience within Quality Assurance, Quality Control or Manufacturing is desirable.
- Understanding of GMP principles and pharmaceutical manufacturing processes.
- Ability to collaborate with internal departments, provide guidance, and maintain effective working relationships.
- Able to communicate observations clearly, prepare accurate documentation and interact effectively with manufacturing personnel.
- Fluency in English, both written and spoken.
- Additional Greek language proficiency relevant to organization’s operations is considered an advantage.
- Excellent knowledge of Microsoft office tools,
- Experience with statistical and data analysis software (e.g., Minitab, JMP, or equivalent).
- Familiarity with quality management systems, electronic document management systems, and manufacturing-related software platforms.
- Ability to analyze, interpret, and present data using digital tools and reporting systems
Why Join Remedica?
At Remedica, we offer a competitive compensation package, including 14 salaries, a provident fund, and a range of additional benefits to support your personal and professional growth. Join our team and be part of a company that values innovation, teamwork, and continuous improvement.
Equal Opportunity Statement
At Remedica, we are committed to ensuring equal pay for equal work and work of equal value. To support this commitment, roles are evaluated using a structured, gender‑neutral job evaluation framework, which objectively assesses the knowledge, skills, responsibilities, effort, and working conditions associated with each role. This approach helps ensure fair, transparent, and consistent outcomes across the organization.
We welcome applications from all qualified candidates, regardless of sex, race, ethnicity, disability, religion or belief, sexual orientation, gender identity, or age.
