Senior Production Pharmacist
STANDPHARMPvt LTD
Total years of experience :11 years, 5 Months
As senior production pharmacist I oversee the entire Production process. Develop Standard Operating Procedures. Liaise with regulatory authorities for legal processes. Involve in direct reporting to the higher management.
Clinical Research Coordinator Role As Clinical research officer in COVID-19 vaccine trial:
• Led a Multi-centered Double-Blind Randomized Clinical Trial on COVID-19 vaccine as the study lead. Sponsored by Cansino Biologics. (China)
• Recruited, screened, scheduled, and enrolled Study eligible participants.
• Collaborated with Principal Investigator, sponsors, and stakeholders to oversee clinical trial research activities.
• Ensured completion of CRF, TMF, ISF, data accuracy, and managed administrative tasks. Ensure timely data entry in trial specific electronic data capturing software DACIMA.
• IP management.
• Liaised with Clinical research organizations for arranging and scheduled site visits.
• Liaised with laboratory staff for sample storage, processing and shipment.
• Acted as a point of reference for study participants and researchers, addressing queries and providing updates.
• Identifying the near misses.
• Safety reporting to national bodies and global pharmacovigilance team.
Role as Clinical Research Coordinator in Institutional Research:
• Screening of Epithelial ovarian cancer and oral cancer Multi-disciplinary team meeting lists for eligible cases.
• Scheduling, consenting and enrollments of Eligible patients.
• Completions of Case report forms.
• Communication with Institutional Review board for amendment approvals and other study related submissions. Direct reporting to principal Investigator.
• Recruitment of Healthy controls.
Role As IRB (Institutional Review Board) assistant:
• Interprets IRB procedures, practices, and offering guidance to researchers regarding the new submissions of Research studies.
• Ensure the Confidentiality of Research Office documents.
• Ensure the completion of all necessary documents of new submissions prior to the IRB meeting.
• Serve as a point of reference for all IRB related tasks and initiatives, including the communication between IRB Board and research staff.
• Coordinate the attendance of IRB members for monthly meetings.
• Attend the monthly IRB meeting and take notes to prepare the meeting minutes.
• Submission of COVID-19 Trial related SAEs, Protocol amendments to IRB.
Role As Infection control linkliner:
• Act as a linkliner between different sections of hospital and infection control department.
• Conduct monthly audits of assigned area and submit reports directly to Infection control head.
• Train and mentor staff members on Hospital acquired infections.
• Promptly reporting to the nurse any evidence of infection.
• Monitoring the hygiene consistent with policies and good infection control practice.
Other ad-hoc tasks
• Support in ethic maintenance.
• Create notes on protocol, workload, data collection and more.
• Prepare supporting documents for liaison with external auditors based on their requirements.
• Work collaborate with data and regulatory teams to make sure the collection of high quality data and regulatory compliance through the trial.
• Dispensing of prescription and Over-the-conter medicines to public.
• Review the prescriptions from doctors to ensure accuracy and suitability for the patients.
• Supervise the preparation of reconciliation medicines.
• Maintain the accurate Pharmacy records, patient profiles, charge system profiles and inventories.
• Maintain the register for controlled drugs for legal and stock control purpose.
• Advise the public on medicine, side-effects of medicines and minor ailments.
• Educate, supervise and train the pharmacy staff.
• Manage the pharmacy finances and medicine budgets.
• Make orders for medical supplies and pharmaceutical supplies.
As a production pharmacist my key responsibility to report the Production manager. Contribution to drug formulation, quality control, regulatory compliance and production management to ensure the safe and effective medication production.
Key Responsibilities:
• Play pivotal role in Drug formulation and development.
• Quality assurance and control.
• Production management.
• Regulatory compliance and risk assessment and management.
Drug formulation and development:
• Collaborate with chemists to optimize the drug composition, dosage form, delivery system, ensure safety and efficacy.
Quality assurance and control:
• Involve in implementation of quality assurance protocols.
• Conduct Audits to ensure the compliance with regulatory requirements.
• Identifying the quality deviations and initiate CAPA. (Corrective and Preventive action).
Production management:
• Oversee the entire production process.
• Develop SOPs, optimize the whole production workflow.
• Coordinate with different sections to meet the required production demands while maintaining quality standards.
Regulatory compliance:
• Make sure the compliance of manufacturing processes with GMP standards.
• Collaborate with regulatory authorities during inspections.
Risk assessment:
• Identifying and mitigate the potential risks in manufacturing lines.
• Proactively address the hazards like cross contamination and equipment failures to maintain the product integrity.
• Mentor over 25 Intermediate students who wanted to pursue their careers in Medical field.
• Participated in teacher meetings, designed to make the teaching method effective interesting and informative.
• Collaborate with colleagues to promote the cross-culture and come up with new ideas.
• Uncover new learning opportunities.
Throughout my MPhil program, I conducted research on drug development and assessed the toxicological impact of contemporary anticancer drugs compared to traditional formulations. The focus was on mitigating side effects during cancer treatment through advancements in drug formulations. This research was published in the JDDST journal, with an impact factor of 5.
In my bachelor's degree, I studied various specialities including pharmaceutics, Pharmacology, Forensic, Pharmaceutical chemistry. I gained excessive knowledge of pharmaceuticals, their formulating methods, their Pharmacology, quality control, that I am using in my career to serve the community.