Amartey P.

Increased compliance with Standard Operating Procedures across various departments to 100%. Ensured timely approval of specifications for Raw Materials, Packing Materials, Intermediates, and Finished Goods, maintaining no backlogs. Addressed complaints regarding regulatory queries and product quality to eliminate issues. Led process validations, cleaning validations, and hold time studies, while promoting compliance through a validation team. Cleared backlogs from FDA cGMP inspections and managed Corrective and Preventive Actions. Verified batch manufacturing and packing records for timely release or rejection of finished products. Developed and delivered training programs for personnel. Collaborated with the engineering unit to prevent equipment breakdowns by implementing a preventive maintenance schedule. Established policies on hygiene, sanitation, and cleanliness across the factory. Developed documentation strategies for deviations, change controls, and investigations. Monitored the performance of the HVAC, Water system, and utilities used in manufacturing. Functioned in support of internal audit programs to foster compliance and collaboration within production groups. Managed control samples and ensured the upkeep of control samples room.

Established a manufacturing system to ensure batch records conformed to Market Authorization and Manufacturing Authorization. Fostered a culture of compliance with GMP and GDP principles during production, storage, and distribution. Coordinated with Quality Control to conduct necessary checks and tests while reviewing manufacturing and packaging conditions. Made decisions on the approval or rejection of starting materials and finished products. Enforced a streamlined change and deviation management procedure within documentation processes prior to product release. Confirmed that all manufacturing documentation was completed and sanctioned by authorized staff. Approved specifications and quality procedures, and facilitated regular training sessions on cGMP and GDP for employees. Oversaw all QC laboratory activities and maintained Standard Operating Procedures. Controlled the storage and preparation of reference standards and managed the inventory of chemical reagents and supplies. Handled document control within the QC laboratory and reviewed analytical work results. Implemented an internal calibration program for laboratory instruments and conducted training for QC personnel.

Assisted in producing executive summaries of parliamentary business. Drafted reports and minutes for committee activities. Performed various administrative duties.

Monitored cGMP compliance throughout the manufacturing process on the production floor. Supervised the dispensing of starting materials for production batches. Conducted sampling of in-process products for quality control analysis and reviewed manufacturing records online. Certified line clearance for production and dispensing activities while performing in-process checks during packaging. Analyzed various pharmaceutical materials and calibrated laboratory instruments such as HPLC and UV spectrophotometers. Documented all QC laboratory work related to cGMP.