Tomasz Gajowiec

- ensure through monitoring that the Production, Packaging, Quality
Control, Warehouse and Maintenance operations and procedures are
maintained in accordance with cGMP,
- ensure master packaging records are updated and maintained as
necessary,
- provide QA support to the Production, Packaging, Maintenance and
Quality Control departments,
- assess and advise on deviations and other issues as appropriate
within the relevant departments,
- review of Batch Manufacturing Records,Batch Packaging Records and
Analytical Reports in preparation for QP disposition,
- initiate updates to Standard Operating Procedures as required,
- assist in the preparation of Customer and Regulatory Audits,
- performance of Self Inspections and preparation of internal audit
reports,
- involvement in training,
- involvement in Customer Complaint investigation and other customer
queries,
- involvement in Deviation investigations,
- involvement in Out of Specification investigations

- testing of all laboratory samples including raw material,
in-process, finished products, validation and stability,
- performance of laboratory tests as per written procedure or
as per pharmacopoeia,
- reviewing of finished product raw data,
- training of QC Analysts,
- sending laboratory samples out for contract analysis,
- carrying out environmental monitoring for the production and
packaging facilities,
- to be responsible for the maintenance of Pharmacopeias standard
and impurity stock levels,
- to sign-in finished products upon receipt into the laboratory,
- to carry out maintenance (sanitization) of the purified water
system,
- operation, maintenance and calibration of laboratory
equipment,
- to report any OOS results, equipment malfunctions,accidents to the
Quality Control Supervisor

- Manufacturing all products according to the correct
procedures (SOPs) and with strict adherence to GMP and safety
procedures
- Dispensing of all raw materials
- Training of production operators
- Cleaning of all equipment/rooms, assembling and calibrating
production and test equipment