To pursue my career in the field of clinical research in an organization where competency and professionalism are highly valued, and my skills are fully utilized and developed. With 4 years of professional experience, I am confident, hardworking enthusiastic and energetic person with an ability to learn and to adapt quickly to changing circumstances and I like to accept challenges and tackle them ardently even when under pressure.
• Monitor production activities in a shift by managing available resources to achieve production target.
• Maintain and monitor standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality.
• Prepare manufacturing records and update documentation to meet production and cGMP requirements.
• Identify the deficiencies/errors and propose new ideas and suggest improvements to reduce the complexity in processes.
Perform the IPQC Testing
• To Generate CAPA and Monitor the action taken against CAPA.
• Participating in self inspections, regulatory inspections and internal audit.
• Record observations at each step on inspection sheet.
• Check the Temperature and humidity record of all areas.
• Check the BMR Record & Maintain it.
• Help in repacking in Material.
• Maintain the sale return record.
• Check the Calibration Record.
• Maintaining the cleanliness in all areas & to maintain it record.
• Maintaince of sterile area, and monitoring of all activities of sterile area.
• Writing of quality documentation including validation protocols and reports, change controls and GMP deviations.
• Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
• Knowledge of GMP and Regulatory requirements and Current Good Manufacturing Practice.
• Writing of quality documentation including validation protocols and reports, change controls and GMP deviations.
• Writing and approving of company Standard Operating Procedures (SOPs).
• Help in validation performance.
• Understanding of the production and packaging process and technology (pharmaceutical & chemical).
• Observing and complying with company Health and Safety Policies.
• Checking of redressed products as per requirement.
Perform the IPQC Testing
• To Generate CAPA and Monitor the action taken against CAPA.
• Participating in self inspections, regulatory inspections and internal audit.
• Record observations at each step on inspection sheet.
• Check the Temperature and humidity record of all areas.
• Check the BMR Record & Maintain it.
• Help in repacking in Material.
• Maintain the sale return record.
• Check the Calibration Record.
• Maintaining the cleanliness in all areas & to maintain it record.
• Maintaince of sterile area, and monitoring of all activities of sterile area.
• Writing of quality documentation including validation protocols and reports, change controls and GMP deviations.
• Working with all members of staff to maintain and develop the positive progressive culture within The Specials Laboratory.
• Knowledge of GMP and Regulatory requirements and Current Good Manufacturing Practice.
• Writing of quality documentation including validation protocols and reports, change controls and GMP deviations.
• Writing and approving of company Standard Operating Procedures (SOPs).
• Help in validation performance.
• Understanding of the production and packaging process and technology (pharmaceutical & chemical).
• Observing and complying with company Health and Safety Policies.
• Checking of redressed products as per requirement.