• Conducts internal and external Compliance Assessments of Actives/Excipients and Packaging Materials supplier facilities based on the EU cGMP
• Develops audit plans, conducts quality audits, prepares audit reports and communicates findings, including compliance risk
• Reviews and evaluates Suppliers audit responses against current regulations and guidelines to assure compliance
• Follows-up on corrective and preventative actions to ensure implementation, compliance and continuing efficacy
• Maintains supplier database and determine final supplier approval status
• Revises, reviews, and writes SOPs and checklists, as needed in order to complete required audit tasks
• Reviews, approves or rejects DMF and other documents needed to be submitted to the competent authorities in order to obtain or renew the Marketing License of company’s products

• University degree in a scientific field (preferably Chemistry or Chemical Engineering)
• Ability to interpret regulatory guidelines/legislation
• High level of integrity & ethical standards
• Excellent time management skills
• Ability to travel both domestically and internationally
• Strong analytical and communication skills
• Problem-solving abilities
• Excellent command of the English language
• Computer literacy with working knowledge of MS Office applications
• Minimum of 2 years of QA/QC experience
• Experience in the pharmaceutical industry and especially in pharmaceutical quality audit will be

• Preparing regulatory submissions (new registrations, renewals, variations) according to the requirements of each country following guidance from Supervisor
• Communicating with internal and external stakeholders responding to queries and requests following guidance from Supervisor.
• Updating departmental databases and reviewing of RIM records to ensure regulatory compliance.
• Assessing Change Requests following feedback from Supervisor for potential regulatory impact
• Informing all departments when approvals and withdrawals are received, registration/ renewal submissions have been sent.
• Compiling and/or preparing dossier sections, updating dossier sections and document versions, ensuring the validity of information to be submitted for all regulatory submissions.
• Monitoring regulations and guidelines relating to products and registration procedures, informing the relevant departments when necessary
• Assisting in the preparation of departmental documents such as procedures and/or SOPs

• University degree in, Pharmacology, Pharmacy, Biology and any other relevant science field
• Previous experience as a Junior RA Officer considered an advantage
• Accuracy and close attention to detail
• Time management skills
• Organisation skills
• Strong written communication skills to provide concise and clear documentation
• Must be able to work in a fast-paced environment.
• Good computer skills
• Excellent knowledge of English language

• Suggest clinical trial designs, provide input to CROs and finalize designs
• Review and approve the BE/pK study protocols
• Analyze data, review/evaluate and approve study reports
• Liaise with pK experts for the assessment of data and reports
• Collaborate cross-functionally, working closely with R&D for pK data needed for formulation development
• Provide feedback advice on strategies for establishing IVIVC
• Manage the BE Study monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
• Track and obtain approval of clinical operations expenses

• BSc in Pharmacy, Pharmacology
• PhD with concentration on Pharmacology or Pharmacokinetics will be considered an advantage
• At least two years’ experience in the generic pharmaceutical industry, preferably clinical trial experience
• Knowledge of Pharmaceutical legislation, Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management are mandatory
• High attention to detail
• Analytical thinking
• Scientific writing experience
• Excellent written and verbal communication skills
• Excellent command of the English Language
• Strong clinical study management skills

• Performing the necessary tests for raw materials, and the products’ intermediate, final and under stability studies, according to written procedures and specifications. Proceeding with the completion of the required documentation.
• Ensuring that all analysis conducted follow the procedures of the analytical methods.
• Checking the documentation and results of the analysis prepared by the QC Department, as and when requested to ensure the validity of the analysis/conformity with regulations.
• Monitoring equipment maintenance needs, keeping the working area clean and tidy and promptly informing Laboratory Engineers of any equipment troubleshooting needed.
• Reporting updates as regards the status of analysis to Supervisors, conducting relevant investigations when necessary.

• University degree in Chemistry, Chemical Engineering or any other relevant field
• MSc will be considered as an advantage
• Excellent knowledge of English language
• Previous experience within pharma industry will be considered an advantage (HPLC, GC/MS, ICP, TLC, LC/MS, LC/MS/MS, XRD, PSD)
• Excellent organizational skills.
• Ability to work on multiple projects at the same time
• Ability to work as part of a team and individually
• Excellent time management and prioritization skills

• Operates production machinery to produce a variety of pharmaceutical products
• Checks and ensures product compliance to established standards
• Cleans production machinery and equipment
• Executes machine changeovers
• Identifies and reports processing related issues

• High School or Technical School leaving certificate
• 1 year of relevant experience will be considered as an asset
• Good command of the Greek and English language

• Analytical Method Development and Validation.
• Execution of stability studies.
• Carrying out of Method Transfer procedures.
• Testing materials and products under development
• Preparing quality reports.
• Ensuring data integrity and proper documentation of experimental data.
• Achieve departments’ goals.
• Complying with GMP/GLP.

• University degree in Chemistry or Pharmacy.
• Master degree will be considered as an advantage.
• Minimum of 2 years’ experience in Research and Development (Analytical) in Pharmaceutical Industry, handling instrumentation such as HPLC, HPLC-MS, GC.

• Assisting in the development and validation of analytical methods according to ICH guidelines
• Assisting in the execution of stability studies
• Assisting in the execution of Method Transfer/Process validation procedures
• Testing materials and products under development
• Assisting in the preparation of quality reports and other analytical documents
• Ensuring data integrity and proper documentation of experimental data
• Executing calibration activities for pH metres and balances
• Executing cleaning activities of instruments used during analysis

• Degree in Chemistry, Pharmacy or any other relevant field
• HPLC hands on experience is preferred and considered an advantage
• Excellent attention to detail
• Verbal and written communication skills
• Good teamwork skills
• Ability to keep detailed records
• Ability to work under pressure
• Willingness to adjust on a full schedule
• Good command of English language and computer

• Leading a team of analysts, giving support and guidance during their daily work
• Reviewing and evaluating the development and validation of analytical methods and procedures
• Reviewing and evaluating stability study results
• Designing and/or overviewing dissolution method development experiments
• Preparing laboratory documents such as SOPs, protocols and reports.
• Reviewing the documentation and results of the analysis to ensure the validity of the analysis and its conformity with specifications and approve the audit trail, managing out of specification/out of trend procedures if and when needed
• Evaluating deficiencies received by the registration department and providing scientific explanations

• Degree Chemistry, Pharmacy or any other relevant field
• Previous experience with HPLC systems, GC, UV mandatory, Previous experience with method validation an advantage
• Previous experience on pharmaceutical analysis of 4-6 years in QC or R&D roles mandatory
• A Senior Analyst must be obedient organized, cooperative and willing to adjust on a full schedule
• Good time-task allocation and ability to meet project deadlines
• Good leadership skills are of essence
• Attention to Detail
• Analytical Thinking
• To be able to work under pressure
• Good command of English language

• Evaluation of the product technical suitability at Remedica, especially for the critical and complex molecule/product
• Conducting literature research on the originator drug product (RLD)/drug substance prior to the initiation of lab activities, including Product & API patents (if applicable)
• Technical aspects: Designing of the formula & process as per QbD, evaluate equipment feasibility, API physical characterisation, DEC study, feasibility/prototype trials/scale up trials including the optimization of process and process parameters, stability testing in accordance to the specifications
• Works closely with IP and reviews patents and proposes non-infringing strategies for active pharmaceutical ingredients, compositions and manufacturing processes.
• Planning, organising, follow-ups must be made to achieve target timelines among technical teams as per the guidance from the supervisor/Head
• Compiling/reviewing formal documentation required for product registration purposes

• Bachelor in Chemical Engineering, Chemistry and Pharmacy
• Master’s degree in pharmaceutical sciences preferred
• Minimum 5 – 7 years of previous Job experience in pharma sector
• Attention to detail, accurate and precise in recording data and batch information
• Strong analytical skills and mindset
• Good leadership skills are of essence.
• Timely decision making to avoid delays
• Demonstrated ability to work in both independent and team environments
• Ability to work under pressure with minimum supervision. Multi-tasking as per departmental requirement with minimum supervision
• Excellent communication skills
• Good organization skills
• Fluency in English writing and speaking
• Good MS skills (Word, PowerPoint, Excel)

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