Validation Technician ( MCC Temp)

Basic qualifications:

Matric

Bsc or BTech: Engineering, Mechanical or Electrical disciplines

Pharmaceuticals, Pharmacy or related scientific field.

Preferred qualifications:

2 – 3 years in Pharmaceutical Industry

Experience in leading all aspects of the validation life-cycle relating to designing the validation, cleaning, processing, utilities Co-ordinating the validation of manufacturing

Report writing.

Details:

Job Purpose:

To effectively and independently lead all elements of the Validation Lifecycle for all systems comprising equipment (including control and analytical systems), utilities, facilities, IT systems or cleaning processes as assigned at the Cape Town Factory. Provides functional guidance to Quality Assurance, Production, Engineering and Technical personnel. Conducts self-inspections.

Scope:

High job complexity. High level of knowledge, experience and technical expertise required. Knowledge of GSK QMS Policies and processes (as applicable). Ability to work cross functionally.

Essential Job Responsibilities:

  • Responsible for ensuring all aspects of the Validation Lifecycle are in place (leads validation working party) and actively maintained for the systems comprising equipment (including control and analytical systems), facilities, utilities, and IT systems or cleaning processes: Prerequisites for Validation, Planning and Requirements, Verification of Design, Testing and Qualification, Summary Reporting, Maintaining the Validated Status, Decommissioning of Validated Systems. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.
  • Prepares and executes Validation Master Plans, Validation Plans and Protocols for the validation of systems and processes as per latest industry and GSK policies, procedures and guidelines and as advised by Validation Lead. Compiles validation reports documenting the outcome of the validation study (and translation to standard work as per the principles of GPS).
  • Ensures system and process validation status is maintained by performing, coordinating or having input into periodic system, cleaning process and product reviews (as directed by the Validation Lead). Ensures re-validation of systems and cleaning processes as required.
  • Responsible for assessing change control requests, unplanned maintenance activities, non conformances and CAPAs for the impact of change on validation status, assists in developing appropriate change management / CAPA action plans (including revalidation requirements) and supports approved change plans with respect to validation activities.
  • Troubleshoots problems that occur with validated systems and manufacturing cleaning processes and provides technical participation in Root Cause Analysis (RCA) investigations as required.
  • Provides technical input to annual reports, Periodic Product Reviews and internal and external audits.
  • Conducts self inspections and supports internal and regulatory audits.
  • Provides technical expertise with respect to systems or cleaning processes in support of Product Life Cycle Management / Process Robustness and other GSK or site initiatives.
  • Coaches others in his/her area of expertise, ensuring other functions (e.g. Operations, Engineering, Technical) have sufficient system / cleaning process knowledge and understanding to execute their roles.
  • Assists with and performs QMS, GSK internal policy, Global Standard Operating Procedures (GSOPs), CAP and Quality Alert gap analysis.
  • Updates Validation standard operating procedures and conducts staff validation training as required.

Key Performance Area:

1.VALIDATION OF SYSTEMS (equipment (including control and analytical systems), utilities, facilities and IT systems).

Validates systems in accordance with the Site Validation SOPs to ensure compliance to the requirements of the GSK QMS Policies and local Regulatory requirements and MCC, relevant export market regulatory authority and ISO 9000 requirements.

Key Performance Indicators:

1.1Leads Validation Working Party by scheduling regular minuted meetings to co-ordinate validation activities.

1.2Provides input into User Requirements Specification (URS).

1.3Facilitates and participates in Technical Risk Assessments (TRA) as per site agreed schedule:

1.4Prepares the Validation Master Plans, Validation Plans / Protocol(s).

1.5Co-ordinates and documents the Design Qualification (DQ), including preparation of Requirements Traceability Matrix.

1.6Co-ordinates the system risk assessment.

1.7Assists with supplier assessments.

1.8Reviews Factory Acceptance Testing (FAT) Protocol, attends and executes FAT with supplier if required.

1.9Develops the test protocols / scripts and records.

1.10Performs or, oversees the performance of, the required monitoring/tests after commissioning.

1.11Ensures calibration of critical and diagnostic instrumentation and addition to the routine calibration program is identified during qualification.

1.12Provides input into and ensures preparation (or revision) of applicable system standard operating procedures (SOPs).

1.13Liaises with projects, supply planning, departmental personnel and contractors/suppliers as required.

1.14Takes appropriate corrective/remedial or preventive action for non-conformances/failures.

1.15Collates and reviews data.

1.16Prepares the Validation Report(s).

1.17Trains personnel with respect to validation requirements and assists with training with respect to system operation and maintenance.

1.18Facilitates and performs periodic reviews of validated systems. Ensures maintenance of the validated status or initiates appropriate corrective action.

1.19Revalidates systems as per the revalidation program or, as required.

1.20Evaluates change control requests, non conformances and CAPAs for the impact of change on validation status, assists in developing appropriate change management / CAPA action plans and supports approved change plans with respect to validation activities.

Key Performance Indicators:

1.1Computerised Systems:

1.21.1Ensure compliance with internal and external computerised system policies and regulations:

  • Perform gap analysis against GMS and global ITMS system validation policies and GSOPs.
  • Liaise with CSQMS, AEQMS and ITMS system validation specialists across the GSK network in order to share good practice methods and tools.

1.21.2Organise site for computerised system validation activities:

  • Ensure all centrally produced tools, templates and materials are available and relevant to site and are specified in local operating procedures.
  • Maintains the computerised system register

1.21.3Provide and deliver training/mentoring for computerised system validation to all relevant site personnel. Co-ordinate computerised system validation activities:

  • Ensuring key personnel, training and experience is in place before beginning any computerised system validation activities.
  • Provide GxP and regulatory input into computerised system implementation projects with particular focus on impact to patient safety, product quality and record integrity.

1.21.4Monitor/support on-going computer compliance:

  • Perform periodic system reviews ensuring that the systems maintain their validated status.
  • Provide CSV related responses to inspectors/auditors.
  • Develop and maintain links with above-site and regional site validation teams both to learn from and contribute to GSK's validation practices

Key Performance Area:

2.VALIDATION OF CLEANING PROCEDURES.

Validates Cleaning Procedures in accordance with the Site Validation SOPs to ensure compliance to the requirements of the GSK QMS Polices, CAPs and local Regulatory requirements.

Key Performance Indicators:

2.1Leads Validation Working Party by scheduling regular minuted meetings to co-ordinate validation activities.

2.2Ensures that cleaning processes are in alignment with the Cleaning Validation Lifecycle approach (i.e. Process Design and Development; Process Performance Qualification and Continued Process Verification).

2.3Facilitates and participates in Technical Risk Assessments (TRA) as per site agreed schedule:

2.4Provides input into equipment qualification working parties in regard to cleaning validation lifecycle requirements.

2.5Co-ordinates cleaning procedure risk assessments.

2.6Prepares the Validation Master Plans, Validation Plans/Protocols.

2.7Develops, executes and records the sampling and test plans.

2.8Carries out or, oversees the performance of, the required monitoring / test plans.

2.9Investigates processing/procedural problems and/or failures and applies effective remedial action (in consultation with Validation, Technical, Production and QA Management).

1.10Coordinates the various validation activities with production and QA personnel.

2.11Arranges for the analysis of samples.

2.12Collates, summarises and reviews the data.

2.13Ensures preparation (or revision) of applicable system SOPs, standard work and Master Documents.

2.14Prepares the Validation Report(s).

2.15Trains personnel (or assists with the training) with respect to validation requirements and outcomes.

2.16Assures that ongoing monitoring (Continued Process Verification) is in place.

2.17Performs cleaning periodic reviews of validated systems. Ensures maintenance of the validated status or initiates appropriate corrective action.

2.18Revalidates cleaning processes as per the revalidation program or, as required.

2.19Evaluates change control requests for the impact of change on validation status (including updates to product and equipment cleaning matrices as required), assists in developing appropriate change management action plans and supports approved change plans with respect to validation activities.

3.COMPLIANCE

Key Performance Indicators:

3.1Performs self inspections as per schedule and participates in above site and regulatory audits.

3.2Provides input into Periodic Product Reviews.

3.3Provides validation input and completes validation activities as a result of Red Alerts, NCs, CAPAs and CCRs.

3.4Reviews Quality Alerts / Quality Bulletins as required.

3.5Attend monthly Value Stream Quality Councils (VSQC) as required.

4.EHS:

Key Performance Indicators:

4.1Complies with EHS standards and guidelines and Site EHS SOPs.

4.2Provides input into EHS risk assessments for new and existing systems and processes.

4.3Attend weekly stop for safety sessions.

5.GSK PRODUCTION SYSTEM:

Partakes in continuous improvement activities to ensure GSK meet the organisational goal of Zero Accidents, Zero Defect and Zero Waste

Key Performance Indicators:

5.1Initiates or participates in projects to continually improve processes through the application of the GPS standards to everything we do.

5.2Assists with the delivery and achieving the GMS goal of Zero Accidents, Zero Defect and Zero Waste goal on site.

5.3Participates in "visual factory", incorporating 5S.

EXPERIENCE:

Preferably a minimum of 3 years experience in the pharmaceutical industry. Knowledge of GxP requirements, demonstrated experience in leading all aspects of the validation life-cycle relating to system qualification and cleaning process validation and change control. Wide knowledge of manufacturing systems and operations.

TRAINING:

Related GSK policy, systems and processes.

Root Cause Analysis Training

QMS, GSOP, ITMS, CAP, GMP, GPS, EHS. Competency level - Competent. Performance standards / measures: as per requisite training and evaluation.

SOP: Core SOPs and essential SOPs are listed on the myLearning Validation curriculum.

PERSON SPECIFICATION:

Good investigative, communication (verbal and written), logical thought and documentation skills. Demonstrated ability to function within an independent and team environment. Good organisational skills and ability to manage multiple priorities. Customer focused.

Competency level - Competent. Performance standards / measures: determined during the execution of duties and via annual PDP review.

Job Factors:

Knowledge: Knowledge and understanding of GMP, validation principles and procedures, QMS, GSOPs, ETCM guidelines, CAPs and industry standards are required to validate site systems (including computerised systems) and cleaning procedures. Competency level -Competent. Performance standards / measures: Completion of Core SOP training and performance of two system / cleaning procedure validations under supervision.

Proven documentation skills – Competent. Performance standards / measures: Completion of Core SOP training, preparation of validation protocols, test reports and validation reports for two system / process validations under supervision.

Complexity:

High complexity as indicated under 'Essential Job Responsibilities'.

Independent Thinking:

Independent thinking is required for organization and completion of tasks. Needs to take full ownership of the systems or cleaning processes, understanding all the elements of system / cleaning validation lifecycle approach and ensuring compliance and adherence to schedules.

Responsibility:

Refer to `Essential Job Responsibilities' above. Ensures site compliance to Validation Lifecycle with respect to systems and cleaning processes and increasingly stringent regulatory requirements and in doing so supports product robustness and reduces defects and waste.

Annual Strategic

Ensures achievement of relevant Technical objectives.

Contact information:

You may apply for this position online by selecting the Apply now button.

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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Preference will be given to candidates in line with the GSK SA and GSK Consumer Healthcare Equity Plan.


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