Experience

zain pharma limited

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Executive (Validation)

  • Oct 2022 - Present

  Roles: • Review of Site Master File, Validation Master Plan and preparing yearly validation schedule. • Review of validation SOPS• Equipment Qualification: Preparation of Equipment Qualification protocols (URS, DQ, IQ, OQ & PQ)Execution of DQ, IQ, OQ & PQ protocols. • Cleaning Validation: Periodic updating of CV product matrix, Preparation of cleaning validation protocols, executing cleaning validation protocols and compiling of cleaning validation reports• Process Validation: Preparation of process validation protocols, executing processvalidation protocols and compiling of process validation reports.• Utilities; Preparing revalidation protocols and reports on Water, HVAC and Compressed air system. • Hold Time Studies: preparation of hold time study protocols and reports. Determination of hold time for different Intermediates and bulk products according to WHO guidelines. • Calibrations: Ensuring Calibration programme is implemented as per schedule. • In charge of IPQA officers; co-ordinate IPQA officers for implementation of GMP/GDP Show less

• Quality Assurance Officer

  • Feb 2022 - Oct 2022

  Roles:• Handling and coordinating the processing of change control, deviations, root cause and CAPAs to its full circle.• Monitor timely closeout of CAPA related to external audits and ensure its effectiveness.• Ensure effective planning, maintenance and monitoring compliance to all the procedures in relation to Quality management systems.• Retrospective validation data collection, entry and compilation for preparation and trending of data for Annual Product Quality Reviews.• Preparation and review of standard operating procedures (SOPs). • Imparting of SOP trainings and general topics in regards to cGMP compliance in the plant as scheduled on training calendar as per individual training needs identification matrix• Promote awareness of Quality and Regulatory compliance throughout the organization through organized training programs as and when required and participate in training of staff on quality systems to address identified problems• Generation, reviewing, approving, issuing, recording, storing/archiving and retrieval revision of standard operating procedures and batch processing records for commercial distribution purposes• Organizing regular self-inspections/quality audits in coordination with the company pharmacist to appraise the effectiveness and applicability of the quality assurance system.• Review batch records executed by Production to ensure that they are properly worked on. • Verification of daily activities done by Quality assurance in-process personnel in production areas as and when assigned by Quality Assurance Manager.• Preparation of validation protocols. Show less



Aspen SSA : Beta Healthcare pharmacueticals Limited

• Nairobi, Kenya

• In-process quality assurance officer

  • Jan 2020 - Dec 2021

  Roles: • Gave line clearance to approve the start or continuation of each production process. • Diligently discharged duties and responsibilities which included; online in process checks at production areas in tableting, oral liquids, dry powder filling, capsulation, creams and ointments departments. • Product samples withdrawal for routine batches and submitted to quality control for analysis. • Making periodic rounds in core processing areas and secondary areas for spot checks with an objective of identification of potential hazards if any and mostly check on compliance of cGMP in order for the products to conform to quality attributes • Verification of the dispensed raw and packaging materials. • Ensured that product nonconformance was controlled at all levels, and any noncompliance during production process was stopped, product was segregated to prevent mix-ups and properly documented that necessitated action plans to solve the issue. Taking part in market complain investigations and follow up. • Monitored every step of manufacturing process to provide confidence that the manufactured medicinal products met the desired quality and fit for the intended purpose to the final end user. • Assisting in process validation by collection of samples and online data. Show less