Position: REGULATORY & QUALITY ASSISTANT (PHARMACIST/ PHARM TECH).
Deadline: 15 May 2024.
Date posted: 17 Apr 2024.
Location:Dar es Salaam.
Description:
Job Purpose
To support the Responsible Company Pharmacist in the effective implementation, coordination, training and continuous monitoring and evaluation of the Quality, Risk and Safety Management Systems at all levels of the organization.
Responsibilities
Quality Management
- To assist the operations manager in establishing, implementing, and maintaining the quality management systems to ensure their continual improvement throughout the organization.
- Assist in drafting and formulating the required procedures and policies for an effective QMS.
- Assist in training and coaching staff on the quality management systems, programs, policies, and standard operating procedures to ensure compliance with QMS and related processes.
- To assist the Operations manager in ensuring that the internal control policies are in place as per the company policies by liaising with relevant departments or staff to ensure the policies are implemented.
- Liaise with the Operations Manager to get relevant data for dossier preparation, amendments, and query responses post-registration/post-retention/post-variation submissions for timely re-submissions.
- Able to detect deficiencies in CTD (Common Technical Documents) dossiers and make amendments.
- Carry out weekly and random checks of the Narcotics register and timely compilation of the quarterly narcotic return report to be submitted to the Pharmacy and Poisons Board.
- Update the product database with respect to information on registration/retention and variation status, maintain progress reports, and ensure proper record-keeping.
- Maintain a database with information on regulatory requirements for example GMP costs, variation costs.
- Ensure adherence to Good Warehousing Practices and Good Storage Practices
- Ensure proper documentation of destruction of Pharmaceutical Waste Products
- Maintain progress reports of all RA, GDP, GWP and GSP operations.
Risk Management
- To aid in developing the best practices to mitigate business risk.
- Assist in overseeing the implementation and period review of the strategies deployed.
- Assist in coordinating GDP activities in collaboration with company pharmacist and warehouse manager.
- Assist the Responsible Pharmacist in monitoring the effectiveness of GDP requirements implemented within the organization.
Healthy and Safety Management
- In collaboration with the Human Resource Department the Quality Responsible is involved in driving compliance throughout the organization and providing assistance, advice and coaching to staff on the management of OHS systems, programs and procedures to ensure compliance with legislation and industry best practice.
Regulatory
- Assist the Responsible Pharmacist in coordinating regulatory affairs during their absence.
- Liaise with Company Pharmacist to get relevant data for dossier preparation, amendments and query responses post-registration/post-retention/post-variation submissions for timely re-submissions.
- Able to detect deficiencies on CTD (Common Technical Documents) dossiers and make amendments Carry out weekly and random checks of the Narcotics register and timely compilation of the quarterly narcotic return report to be submitted to the Pharmacy and Poisons Board
- Update the product database with respect to information on registration/retention and variation status, maintain progress reports and ensure proper record keeping.
- Maintain a database with information on regulatory requirements for example GMP costs, variation costs.
- Ensure adherence to Good Warehousing Practices and Good Storage Practices
- Ensure proper documentation of destruction of Pharmaceutical Waste Products
- Maintain progress reports of all RA, GDP, GWP and GSP operations.
Pharmacovigilance
- Training and coaching staff on ADRs, PV and medication recall
- Prepare quarterly PV reports for submission to suppliers.
- Coordinating PV activities/audits in collaboration with the Company Pharmacist, Marketing Team and Warehouse Manager
Facility Management
- Oversee the management of the site's GDP facilities and equipment to ensure they are in operation state.
- Liaise with service providers for scheduling of preventive maintenance of equipment's and their repairs.
Other related duties
- Interact with the Operations and Sales and Marketing departments in ensuring the timely launch of pharmaceutical products especially with regard to regulatory issues.
- Keeping track of the changing legislation and industry changes
- Performing other duties as assigned by the supervisor from time to time.
Qualifications, Experience & Knowledge requirements
- Diploma/Degree in Pharmaceutical technology
- Experience in the field for 2+ years.
- Knowledge requirements include Quality Management Systems, Occupational Health & Safety and Good Distribution Practices for Pharmaceuticals.
- Must be a pharmacist or have a diploma in Pharmacy and be registered by the relevant body.