- Ensure that Maintenance/Repair contract are in place and up to date for each instrument.
- Liaise with QC/Manufacture/Engineering to ensure that repairs are performed in an efficient manner with minimum impacts on current activities and manage equipment scheduling with planned activities.
- Liaise with approved and trained engineers for on-site and external work.
- Perform basic trouble shooting investigations or ask for SME support in order to facilitate discussion with the engineers.
- Ensure that the site induction for engineers is conducted to apply safety and quality rules at any time and be their point of contact.
- Organise dispatches when applicable, including communication and documentation.
- Perform all SAP associated actions for quote/payment and invoice queries via Readsoft.
- Work on quality documentation (RFC, Deviation, Investigation, CAPA) and progress them with the support of Senior QC staff members where applicable. Escalate any quality impact immediately.
- Review/approval of engineer documentation and record any relevant information in instrument log as per procedure.
- Ensure that Maintenance/Repair contracts are in place and up to date for each instrument.
- Liaise with QC/Manufacture/Engineering to ensure that maintenance, calibration and qualification activities are performed in an efficient manner with minimum impacts on current activities.
- Liaise with external contractors, internal engineering department and equipment users to minimise down time and ensure good performance of equipment at any time.
- Ensure that the site induction for engineers is conducted to apply safety and quality rules at any time and be their point of contact.
- Review/approval of engineer documentation and record any relevant information in instrument log as per procedures.
- Escalate any issue and raise any quality documentation (RFC, Deviation, Investigation, CAPA) and progress them with the support of Senior QC staff members where applicable.
- Track/trend maintenance activities.
- Identify new instruments/instrument replacement needs and liaise with QC Team Leaders/QC Manager to ensure that they are aligned with current activities needs.
- Identify suppliers.
- Obtain quotes.
- Write up URS in collaboration with Senior QC staff members, Q&V, DI and IT.
- Liaise between Finance department, QC Senior staff members and Procurement department to progress the CAPEX and associated presentation where applicable.
- Liaise with the IT department & DI specialist to identify any needs for software installation, data storage, user creation.
- Support DQ/IQ/OQ and ensure that supplier documentations meet the company GMP requirement. With the support of the Q&V department and DI specialist identify gaps and provide RA or complementary documentation (Validation Protocols, Test scripts).
- Support PQ performed by supplier and Q&V department by writing and/or reviewing protocols and reports with the support of Senior QC staff where applicable.
- Perform the review of the reports with the support of QC Senior analysts where applicable.
- Support the transfer of ownership of new equipment to the QC system owners.
- Support the training for the use of the new instruments.
- Support the writing of the new user documents.
- Support the archive activities for old instrument and associated documentation.
- Attention to details
- Reliability
- Effective communication
- Ability to follow instructions accurately
- Ability to manage and schedule workload
- Understanding of hardware, software and data integrity
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QC Equipment Specialist - Falkirk, United Kingdom - Piramal Group
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Description
- Key Roles/Responsibilities:
.Execute, manage and co-ordinate the repair of equipment
. Execute, manage and co-ordinate the maintenance, calibration and qualification of routine QC equipment
the procurement of new equipment and software
.Support and perform periodic review of QC equipment and track and trend those activities.
.Perform Administration activities for analytical software (Empower, Spectrum...)
actively on QMS record to maintain the compliance expectation.
.Immediately escalate and report any deviations relating to materials, facilities, processes and procedures to the QC Manager.
.Conduct all activities in the most careful and safe manner and in full compliance with ESH requirements.
.Support change controls, deviations, OOS and SST investigations and CAPA's in the most diligent manner.
.Identify area for Continuous Improvement and escalate to the QC Manager. Take part in the implementations changes as part of a team project.
.Actively contribute to the development and maintenance of an enthusiastic, supportive and collaborative environment within the team setting.
undertake any other duties as requested by the line manager in accordance with company requirements.
-Competencies:
