Responsibilities

Developing technical documentation for products (technical files/design dossiers) for drug regulatory authority of Pakistan, WHO Prequalification, notified body and customers.
Designing & implementing the organizations system in accordance with ISO 9001, ISO 13485 & Medical Device Directive 93/42/EEC.
Leading all internal and external audits and inspections.
Developing ETO Sterilization reports and validates the process with team support.
Performing validations of critical processes.
Developing equipment validations.
Monitoring and verifying incoming inspection and testing for raw materials, packaging materials and supplier provided samples.
Monitoring the process of supplier evaluation in the concern of purchase department.
Monitoring and verifying production activities, in process inspections, QC testing in accordance with applicable standards and customer requirements.
Monitoring equipment maintenance and EMS departments.
Determined training needs and assessments and conduct training sessions with HR.

Achievements

Participated customer audit (Unicef) activity and developed documents according to MDD & ISO 13485 with team support and fortunately company got the tender from Unicef.
Updated the Quality management system in accordance with upgraded standards ISO 9001:2015 and ISO 13485:2016 and successfully achieved the recommendation for new certification by the certification and notified body.
Submit the technical documentation of auto destructible syringes to notified body and successfully extend the scope of CE marking.
Participated in audit conducted by Drug Regulatory Authority of Pakistan with team member and successfully achieved the new license for Manufacturing, sale and storage of medical devices.
Prepared product dossiers for word health organization prequalification and successfully achieved the WHO certification.
Developed product Catalogs.
Prepared PAHO tender submission and successfully got the tender.

Responsibilities

Making clinical rationales/ literature search protocols, the literature search reports and search of relevant references for equivalent or similar devices to claim the device is for safe use and already well-known in national and international market.
Participating in Designing & implementing the organizations system in accordance with ISO 9001, ISO 13485 & environmental management system ISO 14001 & handling audit activities in their premises.
Contributing in developing formats and required documents to making medical devices technical files for customers and notified body. 
Participating to developing ETO Sterilization reports (given Guidelines from CEO).

Achievements

Developed EO Validation report (in the association with CEO) for second party and it was successfully accepted by them.
Developed disinfectant validation report for an international brand “Alexander” it was successfully accepted and appreciated by second party.
Developed product shelf life claim (given guidance of CEO) for a foreigner company SC SPD STAR SRL and closed their major nonconformance on first attempt.

Responsibilities

Implemented requirements of Quality Management Systems (ISO 9001& ISO 13485) & Environmental Management system (ISO 14001) in the association of team members.
Assessed customer requirements and ensuring that these are met.
specifying quality requirements of raw materials with suppliers
Investigated customer complaints made sure to corrective actions have been taken & implemented.
Ensured that manufacturing processes comply with standards at both national and international level
Worked with operating staff to establish manual, standard operating procedures, formats, process flows in association with consultant.
Written management and technical reports for customers & Notified Body.
Determined training needs and assessment.
Monitoring performance
Supervised technical & External Sources (calibrations, environmental testing, clean room testing, sterilization batch records and performance.
Handling and preparing the internal and external audit requirements in the association with consultant.

Achievements

Participated in registration process of class I devices on the panel of European Representatives.  Participated to add Class IIa & Class IIb devices in notified body CE marking directive scope.
Taken part for handling incidents till their closure.
Contributed in developing EO Sterilization Validations in the association with consultant and EO supplier.
Design Quality Management system according the compliance of ISO 9001, 13485, 14001 & Directive in association with consultant.
Made different product specifications for customers.

Talk shows
Attaining interviews of Celebrities
Musical Programs
Discussion on different topics with callers