Assistant Manager Validation

Job Description

Site Name: Pakistan - Sindh - Karachi Posted Date: May 10 2022 Job Purpose To ensure compliance with local regulatory requirements and QMS related to validation by managing & performing validation studies of facility, utilities, equipment, laboratories, computerized systems and processes that have an impact on the quality of GMP regulated products and building quality into all quality critical systems. Education & Experience: M.Sc. / B. Pharm. / Pharm D 2-3 years of experience in QMS / Validation / Production/ Quality Key Responsibilities: To ensure all facilities equipment and operations at site are validated (DQ, IQ, OQ, PQ) in line with regulatory and corporate requirements. To provide validation support to the continuous improvement automation of corporate projects in an environment of rapid change To coordinate / complete validation of new non-lactam sterile project within defined timeline. To coordinate with multi-functional validation working party (VWP) in achieving validation targets as per defined timelines. To prepare data for update of validation activities for site Quality Council Meeting Site Validation Master Plan Create and Maintaining Site Validation Master Plan (SVMP) in compliance with the group quality policies and regulatory requirements. Create and Maintaining VMPs as appropriate for new projects such as upgrades to facilities, new product induction Coordinate with engineering department in order to ensure availability of DQ, IQ, and OQ. Performance Qualification Protocols: Creating / facilitating validation protocols which fulfill current compliance requirements Consulting with production, quality function, stores and engineering Managing changes to validation protocols Continuous improvement, periodic review and collaborating with user departments and support groups Preparation of Validation summary reports to meet customers and release deadlines. Cleaning Validation and Verification: Validation of cleaning procedures of production related equipment Preparation of cleaning validation protocols for new manufacturing and filling equipment and or to incorporate changes or products. Preparation of cleaning verification protocol for non-routine production activities. Coordinate to carry out cleaning validation exercise with Planning, Production and Lab Operations. Periodic Reviews: Periodically reviewing validated manufacturing and filling process, equipment, utilities, facilities, cleaning processes in order to ensure that they remain in validated status. Audit Readiness: Being ready for audit all the time. Ensuring that all the validation documentation is complete, accurate and accessible. Participating in audit preparation and related training Manufacturing of trial/experimental batches: Time to time monitoring of trial/experimental batches being manufactured at site and ensure compliance. Training: Ensure that the trainings on validation related SOPs have been delivered in time to all the stakes holders. To ensure that all the SOPs related to Validation department are in place and in use. QMS Implementation: To keep Validation department in line with the GOPs and GQMPs related to Validation. To Participate in GAP analysis session related to Validation Sterile Non-Lactam Project To prepare VMP of Non-Lactam sterile project To conduct VWP sterile project meeting in regular basis To follow up validation status of DQ/IQ/OQ/PQ status To participate in PQ of sterile area equipment To prepare volition protocol/reports of product validation and cleaning validation of equipment. 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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