Validation Manager

Job Description

Site Name: Pakistan - Sindh - Karachi Posted Date: May 31 2022 Job Purpose The role provides an expert input to lead regulatory and quality compliance for the Validation This role is to ensure that the sites products, area and equipment consistently and reproducibly meet the pre-determined specifications by using appropriate challenging conditions. Ensures that the sites products continuously meet current local regulatory and QMS requirements and major change projects get timely approval by regulatory authorities and internal stakeholders. To ensure validation studies of facility, utilities, equipment, laboratories, computerized systems and processes that have an impact on all quality critical systems. Education & Experience: Science degree (B.Pharm / M.Pharm/Pharm D / B.S. / M.Sc. Chemistry) Specialized Knowledge: Breadth & depth across disciplines or functions; expertise in field required Good writing and communication skills. Knowledge of Drug laws / local Regulations and of GLP, GMP, GDP etc. Facilitation Skills A strong working knowledge of corporate IT systems is essential. 5+ years of relevant experience Key Responsibilities: Validation activities: To review and ensure the schedule adherence of Site Validation Master Plan (SVMP) To assure that all departments have updated Validation Master Plan (VMP) in place and validation activities are reported and run to schedule. To ensure all facilities equipment and operations at site are validated (DQ, IQ, OQ, PQ) in line with regulatory and corporate requirements. To assure that PQ protocol for manufacturing equipments, Process Validation protocols for products, Cleaning Validation protocols are timely developed and validation is performed as per approved protocols. To ensure timely development i.e. Preparation. Approval and issuance of Validation and Validation Summary Reports To assure the checking and approval of protocols and reports of manufacturing Equipments in stipulated time. To ensure implementation of CSV by following corporate policies and procedures (AEQMS, CSQMS, ITMS and spreadsheet) and develop Standard Operating Procedure of CSV and ensure that computer system registers, and related protocols and reports are executed to schedule as per approved procedure in accordance with requirements of QMS. To provide validation support to the continuous improvement automation of corporate projects in an environment of rapid change To coordinate with multi-functional validation working party (VWP) in achieving validation targets as per defined timelines. PQ / Process Validation and related activities. To ensure timely development of PQ/ Process Validation Protocols of manufacturing equipments and products. To ensure that PQ/ Process Validation of manufacturing equipments and products. To prepare PQ/Process Validation Reports / summary reports of manufacturing equipments and products. Responsible for review and interpretation of environmental monitoring results for facility validation. Cleaning Validation & Environmental Monitoring and related activities. To ensure timely development of Cleaning Validation Protocols of manufacturing equipments. To ensure Cleaning Validation of manufacturing equipments is performed as per schedule. To ensure timely development of Cleaning Validation Reports of manufacturing equipments. To ensure timely development of Environmental Monitoring Protocols of manufacturing facilities. To ensure that Environmental Monitoring of manufacturing facilities is performed as per approved procedures. To ensure timely development of Environmental Monitoring Reports of manufacturing facilities. Utilities Validation (Potable Water, Purified Water, Compressed Air and Forced Air). To ensure timely development of Utility Validation Protocols of manufacturing facilities. To ensure timely development of Utility Validation of manufacturing facilities. To ensure timely development of Utility Validation Reports of manufacturing facilities. Computer System Validation To ensure timely completion of CSV of all quality critical equipment Trial/experimental/rework/reprocess batches Ensure the monitoring of trial/experimental/rework/reprocess batches being manufactured at site and ensure compliance. Periodic Reviews: Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status. Retention of validation records. To ensure timely development review and management of Departmental SOPs. Assist Change Controls and Deviations requirements where applicable and being a change control panel member endorse the Change Control activity. Coordination with stakeholders for timely execution of all Validation activities. Any other responsibility assigned from time to time as per business requirements Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies 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 GSKs 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.

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