Posted on :
22 Nov, 2016
22 Nov, 2016
Tests compliance of products samples to specification and tests compliance of utility/environmental samples to specified limits.
High analytical / product complexity. High range of experience and technical expertise required.
Essential Job Responsibilities:
Key Performance Area Key Performance Indicators
Tests all product samples for compliance to microbiological attributes as per product specification.
Tests utility and environmental samples for compliance to pertinent system SOPs.
1.1 Samples and tests raw materials and products as per SOP and specifications.
1.2 Samples and tests utilities as per system SOPs and test program.
1.3 Performs environmental monitoring in all areas (Sterile, non-sterile production areas and support areas) as per SOP and test program.
1.4 Enumerates and identifies microbiological organisms as per SOP requirements.
1.5 Performs preservative efficacy tests (products and cleaning agents) as per SOP.
1.6 Ensures that applicable SOPs are followed and required records are completed.
1.7 Examines samples critically.
1.8 Records results as per GLP requirements.
1.9 Reviews results for accuracy and reports any anomalies or non-conformances to Manager.
1.10 Implements OOS procedure where necessary.
1.11 Performs `peer review’ of microbiological test results.
2. Compliance GLP & QMS
Complies with the requirements of Good Laboratory Practice and the requirements of the applicable GSK QMS Policies..
Supports the value streams.
Supports cleaning validation and process validation activities.
2.1 Ensures cleanliness of working and surrounding area.
2.2 Ensures preparation and storage of reagents as per SOPs.
2.3 Ensures that reagents and supplies are ordered timeously.
2.4 Ensures that SOPs in use are current and notifies the Manager of any out-of-date procedures.
2.5 Prepares SOPs as required by the Manager.
2.6 Verifies the calibration status of equipment as required by the Manager.
2.7 Performs maintenance of equipment as required by the Manager.
2.8 Completes appropriate equipment logs after usage, verification and maintenance.
2.9 Assists with the validation of equipment and systems as required by the Manager.
2.10 Performs system monitoring (eg. Room pressures) and completion of appropriate logs as required by the Manager.
2.11 Performs area inspections (self inspections, 6S, EHS) as required by the Manager.
2.12 Ensures that laboratory waste is timeously removed as required by the Manager.
2.13 Interacts with value stream management on matters related to operational and product microbiological quality.
2.14 Provides advice, guidance and training as required by Manager.
2.15 Carries out microbiological tests for cleaning validation and process validation purposes.
3.1 Complies with EHS standards and guidelines and Site EHS SOPs.
3.2 Complies with SOPs wrt safe use of chemicals/reagents, glassware, analytical procedures and the use of PPE.
4. Operational Excellence
Partakes in continuous improvement activities to reduce costs, increase productivity and improve quality.
4.1 Participates in projects to continually improve processes – Lean Lab, OE and Lean sigma methodology.
4.2 Participates in Manufacturing Technology projects e.g.. Bactiflow.
4.3 Assists with the delivery of the financial OE benefits.
4.4 Participates in “visual factory”, incorporating 6S.