Accountable Area: Quality Assurance Department, Production Department, Quality Control Department and R and D Department. RM/PM dispensing, Line clearance and Sampling.
Purpose of the Role
Maintain quality of products, dispensing, sampling, monitoring and documentation.
Responsibilities
A. Preparation & Maintenance of documents:
- 1. Must prepare documents required in Quality Assurance Department and related to National GMP, WHO-GMP, ISO and internal quality management.
- 2. Must prepare SOPs & Protocols.
- 3. Must prepare and conduct process validation. Cleaning validation, qualification programs.
- 4. Review of the document prior to any changes.
- 5. Prepare & check BMR/BPR and ensure that the production is executed in according to with the BMR/BPR.
- 6. Prepare & check other quality related documents.
- 7. Conduct Audit and inspection of all the departments in coordination of the line manager & Develop and implement corrective action & preventive action (CAPA) to address quality issues.
- 8. Investigate, resolve any change controls, quality deviation and complaints and prepare/maintain investigation reports in case of such failure.
- 9. Liaise with other departments on quality related matters.
B. Works related to Regulatory Affairs:
- 1. Prepare and manage documents required by Regulatory Affairs.
- 2. Must do all the necessitous for Manufacturing and Marketing License of developed products.
- 3. Undertake the regular updating of license of Raw Materials, Packing Materials and Finished Products.
- 4. Must prepare the Annual Product Review, Annual Raw Material and Packing Material Consumption report.
- 5. Work in coordination with the GoN, Health Ministry, Home Ministry and Crime Investigation Bureau for the regulation and management of narcotic products in liaison with the DDA.
- 6. Stay-up-to-date on current Good Manufacturing Practice(GMP) regulations.
C. Sampling and Dispensing:
- 1. Must conduct and check sampling of Raw Materials, Packing Materials, Intermediate Products and Finished Products.
- 2. Must conduct and check dispensing of RM/PM/PPM/SPM/TPM in accordance to the released BMR/BPR from QA.
D. Assuring Quality compliance of machineries and factory environment:
- 1. Assurance regulatory compliance and compliance with Factory Operations and Production Management Policy and Medical Affairs Policy.
- 2. Responsible for the certifying line clearance and cleaning certificate.
- 3. Monitor the log book of every department for regular update.
- 4. Monitoring of each department.
- 5. Train & mentor junior QA Officer.
E. Finished Product Release:
- 1. After batch completion, retrieve entire analytical, manufacturing and assurance documents and compile in accordance to the SOP.
- 2. After the requisition from the secondary packaging, must initiate the process of physical inspection and sampling of the particular batch to be released.
- 3. Randomly or entirely, inspect or sample the products packed. May open the tertiary, secondary and even primary packaging for entire spectrum of inspections and for preparation of final release and forwarding to the releasing authority.
- 4. When completed, must avail during the transfer of released product(s) from secondary packaging to the finished goods quarantine.
Key working relationships (cross functional relationship)
Cross functional relationship with entire departments of the factory in coordination with the line manager. Internally this job interacts with the department lead and colleague of the Quality Assurance department. Need to be in solid line reporting to the department lead.
Professional Competencies
- Bachelor in Pharmacy.
- 1 or 2 yrs of experience in Quality Assurance Department.
- Basic skills in Microsoft Office.
Behavioral Competencies
- Integrity (Instils trust).
- Authentic – communication, behavior & actions customer focus.
- Manage the professional & procedural ambiguity plans & alignment with actionable.
- Courageous and soundly confident.
- Flexibility & Adaptability.
- Hard working & practices prioritization.
Best Wishes
Toreva Human Resources & Talent Management Function.
