I have spent 22years in the pharmaceutical industry specialising in sterile manufacture and release. I occupied positions in Production, Quality and Pharmaceutical Services. Positions have ranged in Production from Production Pharmacist to Production Compliance Pharmacist to Production Department Manager; in Quality as Quality Systems Pharmacist and Batch Release Pharmacist and finally in Pharmaceutical Services as Responsible Pharmacist(Qualified Person). Levels have ranged from Junior level to Middle Management and eventually to Executive level. In all levels there has always been managing and leading of people and processes. For the last 2.5yrs I have been consulting in the same industry. Through this role I have been able to use my skills acquired to assist in/drive projects that need skilled and specialist focus. My skills/strengths are my attention to detail, ability to teach and train personnel, my focus on quality, on striving for "right - first - time", my people skills, my focus on system analysis to identify shortcomings and then putting systems in place to improve them and being driven to complete all tasks set for me in the required time frame.I go the extra mile....always...not because I want to impress anyone but because of my commitment to perform.My motto in life and career is "lead by example" and "even if you stand alone, fight for what is right and ethical". Only through this way of life can one inspire others to follow and in doing so, being confident that they will always do what's right ...even when no one is looking.
Self-Employed
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Independent Pharmaceutical ConsultantSelf-Employed Feb 2019 - Present
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Business OwnerGravity Indoor Trampoline Park, East London Jan 2019 - PresentEast London
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LocumLocum Jul 2017 - PresentPort Elizabeth Area, South AfricaLocum: Retail and Warehousing
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Document Release Pharmacist (Product Release Manager)Aspen Pharma Port Elizabeth Nov 2017 - Dec 2018Port Elizabeth Area, South AfricaLocum role until made permanent in May 2018 -
Svp Hormonal (Hazardous Substances) Compliance PharmacistFresenius Kabi Nov 2015 - Jun 2017Port Elizabeth Area, South AfricaResponsibilities : • Responsible for the assessment of production processes in order to establish level of compliance versus pharmaceutical standards.• Conduct product anomaly investigations and complete CAPA actions report to prevent re-occurrence of anomaly incident.• Responsible for the recipe creation, implementation and recipe maintenance of the Automated Petogen Mixing System (APMS).• Performs departmental internal audits to establish level of compliance and necessary corrective actions to close gaps identified.• Participates in external departmental audits and the completion of the subsequent audit finding report.• Conduct ad hoc product studies or trials as part of process improvement initiatives.• Responsible for writing, reviewing and updating departmental Standard Operating Procedures.• Conduct training initiatives within the department to ensure that all staff is properly trained and competent to perform their job function.• Responsible for the identification of process improvement opportunities in order to prevent product loss and unnecessary product discard.• Occasionally perform duties of Production Pharmacist as follows:- Ensures that his/her supervisors/team leaders are conversant with daily production program and organizes the department’s activities accordingly.- Identifies and addresses daily production problems- Reports / liaises daily with the Department Manager on the production situation.- Performs department pharmaceutical duties.- Is responsible for department productivity and loss control (labour, money, machines)- Ensures that the daily production program and targets are met.- Carries out ‘second line’ management function for staff problems/disputes.- Responsible for the department compliance with factory rules and regulations.- Responsible for the accurate completion and reconciliation of departmental batch book documents -
Responsible PharmacistFresenius Kabi Feb 2014 - Oct 2015Port Elizabeth Area, South AfricaResponsibilities : • That the batch, its manufacture and testing comply with the provisions of the marketing authorisation (including the authorisation required for importation where relevant)• That manufacture has been carried out in accordance with GMPs as relevant to the intended market• To record the certification for release in a register• Site compliance with the Pharmacy Act, Medicines and Related Substances Control Act• Implementation, maintenance and compliance with Good Manufacturing Practices (GMP)• Implementation and maintenance of the pharmaceutical quality system (PQS) including but not limited to:- the company's quality manual• Finished Product release• That principal manufacturing and testing processes have been validated• That any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system• Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority; • That all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes; • That all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so• That all audits have been carried out as required by the quality assurance system. • Departmental performance review• To be a primary contact with the EU Qualified Person, as and when required, for all matters requiring evaluation of batches intended for the EU• That there is appropriate communication with the relevant regulatory authorities• Management of medicine registration applications for imported and locally made products• Participate in the FKMSA Management Review meetings and Executive Committee (EXCO)• Manage and review performance of Pharmaceutical Services staff• Budgetary forecasting and control -
See Attached Cv For Details Of Further Prior Experience At Fresenius-KabiFresenius Kabi May 1999 - Feb 2014Port Elizabeth Area, South Africa -
Pharmacist InternDora Nginza Hospital (Public Service) Jan 1998 - Apr 1999Port Elizabeth Area, South AfricaKey responsibilities :Pharmacist responsible for Medical, Surgical, Male and Female wards, Casualty, Gynaecology and labour wards for:• Dispensing and monitoring of treatment side effects, drug interactions and dosings, consultation with doctors, counselling of patients, and liaise with nurses regarding needs in the wards• Control of Schedule 5, 6, 7 registers, generation of statistical reports regarding patients and outpatients• Maintenance of drug protocol in immuno-compromised and TB affected patients• Check outpatient departments, and conduct in-process training of interns in the above mentioned wards• As an intern, I had to assume to role of acting-ward pharmacist in the above wards as well as the Burns Unit and Paediatric Ward• Manufacturing on a small scale• Stock control
Nerine Reshalin Skills
Nerine Reshalin Education Details
Frequently Asked Questions about Nerine Reshalin
What company does Nerine Reshalin work for?
Nerine Reshalin works for Self-Employed
What is Nerine Reshalin's role at the current company?
Nerine Reshalin's current role is Pharmaceutical Consultant.
What schools did Nerine Reshalin attend?
Nerine Reshalin attended Nelson Mandela Metropolitan University, University Of Port Elizabeth.
What skills is Nerine Reshalin known for?
Nerine Reshalin has skills like Quality System, Corrective And Preventive Action, Quality Management, Problem Solving, Standard Operating Procedure, Training, Quality Assurance, Gmp.
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