Panagiotis Gemenetzis

Experience

• 

  Aristotle University of Thessaloniki

  Nov 2004 - Feb 2007

  Research Assistant

  Lab assistant in Environmental Control Laboratory, participation in various scientific subsidiary programs during the elaboration of my thesis.

• 

  Greek Army

  Apr 2007 - Nov 2007

  Chemist Engineer

  Chemist during military service, unit 872 Fuel Warehouse, Spectrometry analysis (ICP-OES) of fuels and lubricants in the context of the Army Oil Analysis Program from vehicles, helicopters, and tanks of the Thraki force.

• 

  Pharmathen

  Mar 2008 - Aug 2022

  Accountable for facilitating and implementing quality risk management. I also participated in quality functions and assured compliance with GMP as well as carried out the review and approval of SOPs to improve organizational performance. My responsibility is to coordinate with the quality assurance and production departments for the monthly programming of releases. I was also engaged in approval of change controls, DIR's and Corrective-Preventive actions as well as approval of product quality records, quality agreements, and site master files.My major contributions include:• Implementing and maintaining quality standards to retain licenses from Competent Authorities to operate. • Delivering a key contribution in batch certification and release - raw materials, finished products, batches for clinical studies in adherence to the requirements of the Marketing Authorisation, principles, and guidelines of cGMP. Show less • Managing a team of 32 employees• Uncovering training and ongoing development opportunities for laboratory personnel.• Directing new project development - sterile injections, arranged chemical and microbiological laboratory.• Playing a key contribution to microbiological lab development/leading.• Co-ordinated with Regulatory Affairs department for ANDA,NDA and EU submissions.• Successfully dealt with Deficiency Letters and Complaints.• Served as a Spokesperson for audits (FDA, SFDA, ANVISA, Greek health authorities, and pharmaceutical companies).• Measuring the performance of the team through KPIs.•. Maintaining direct and indirect costs within budget. Show less Key Responsibilities:• Part of a team responsible for new project development - sterile manufacturing.• Procurement of instruments and consumables.• Implementation of Good Lab Practices.• Preparation of SOPs.• Handling and reviewing of OOS• Preparation of Technical Directives of Instrument’s.• Preparation of change controls, DIR’s and Corrective-Preventive actions.• Water System Validation.• Review of analytical data.• Planning of Internal and External Qualifications.• Participation in microbiological lab development.• Performing Validation of Computerised Systems (Annex 11).• Troubleshooting of Instrument Malfunctions.• Organization and oversight of stability studies Show less • Active participation in the establishment of newly formed pharmaceutical laboratory.• Analysis of API's and Drug products.• Initial validations and stability studies of the transferred manufacturing process to new facilities.• Analytical methods of troubleshooting.• Instrument calibrations and qualification• Resolved instrument malfunctions by ensuring proper maintenance.• Delivered analytical results with minor deviations and out-of-specification results promptly. Show less

  • Quality Control Senior Manager - Long Acting Injectables Unit

    Jul 2022 - Aug 2022

  • Qualified Person

    Feb 2015 - Aug 2022

  • Quality Control Manager - Long Acting Injectables Unit

    Jun 2018 - Jun 2022

  • Quality Control Supervisor - Long Acting Injectables Unit

    Jun 2015 - May 2018

  • Chemical Lab Supervisor - Oral Dosage Forms Unit

    Jan 2010 - May 2015

  • Senior Chemical Lab Analyst

    Sept 2008 - Dec 2009

  • Chemical Lab Analyst

    Mar 2008 - Aug 2008
• 

  Association of Greek Chemists-Division of Eastern Macedonia and Thrace (Greece)

  Jan 2019 - Dec 2024

  President
• 

  ANFARM

  Sept 2022 - now

  Director Quality Operations

  • Accountable for the performance of the Quality Operations, consisting of Quality assurance, Quality control, and working closely with Qualified Persons to ensure the timely release of batches (lyophilized products, LV and SV injectables, tablets, capsules, sterile bags, creams).• Oversee and assign staff to prepare status and tracking reports on assigned projects, provide regular briefs to executive management, and coordinate unit-wide activities and projects that require quality support or approval.• Liaise with other disciplines of the company to provide support for releasing products on time and within budget and/or support in complying with appropriate corporate procedures and fostering improvement initiatives• Lead and provide guidance during and following internal and external audits and inspections.• Represent the company towards customers and authorities to negotiate and close quality agreements or solve quality-related observations.• Keep track of developments in the field of QP / Product Release, Quality Improvement, Complaint Management, Document Management, Quality Systems, and Quality Control.• Lead the risk assessment and mitigation processes whereby risk components are evaluated according to their likelihood of occurring and potential impact should they occur.• Ensures accurate, timely, and efficient practices related to managing CAPAs.• Recruits/attracts qualified, knowledgeable colleagues and coaches them to reach their performance goals.• Monitors and maintains a safe and healthy work environment. Show less