site qa head in hyderabad

posted
contact
randstad india
position type
permanent
apply now

posted
location
hyderabad, telangana
function
Pharma, healthcare & lifesciences
position type
permanent
experience
15-20
reference number
56008
contact
randstad india

job description

site qa head in hyderabad

## Job Title:|Site Head - QA|## Division|APL| ---|---|---|---|--- ## ## Department ## |QA|## Sub Function| ## Location|Jeedimetla, Hyderabad| # Purpose of the Role: To implement quality management system to achieve effective control onquality. # Key Role and Responsibilities Review and Approval of Annual product quality review documents.Review and Approval of Site Master File, Validation master plan documents forfacility and responsible to keep these documents updated.Review and Approval of Installation/Operational qualificationprotocols/reports for themanufacturing equipment and new facility in co-ordination withProjects/Production departments.Maintaining the records of Job descriptions, Specimen signatures.Review and approval of Quality control instruments qualification/calibrationdocuments.Review and approval of analytical method validations, Vendor Qualification.Review and Approval of Reprocessing / Reworking Batch production records.Review and Approval of performance qualification and process validationprotocols of the Intermediates/ APIs manufactured in the facility.Review and approval of Standard Operating Procedures.Review and approval of technology transfer documents.Review and approval engineering related qualification documents (i.e.validation activities of critical systems including water system and AirHandling system).Review and approval of process flow charts, formats, calibration schedules,maintenance schedules, shift schedules.Review and approval of cleaning validation protocols for the multi-productsmanufactured in the plant.Conducting internal quality audits in the plant, issue reports and follow upfor closure ofnon- conformance.Handling of Change Control procedures.Handling of el SAP related issues w.r.t quality.CAPA management.Preparation of audits responses and follow up for the closure.Review and Approval quality department monthly reports.Handling of deviations /00S/00T/Incidents/Customer complaints/Market returnedgoods and Approval in the track wise.Finished Product batch release after batch manufacturing record review.Review and Approval of Trend Reports of DM water-both chemical and microbialanalysis.Co-ordinating with QA team for all QA related functions.Conducting the GMP Training programs for all employees.Handling of Customer Questionnaires, Dispatches, and Customer Agreements &Quality related documents.Review and Approval of Stability Protocols and Stability Data.Supporting to Regulatory Affairs and Business Development.Responsible for approving the induction certificates, Annual TrainingCurriculum,Training Group creation logbook, Annual training calendar trainingcoordinators, Qualified trainer list, Job descriptions and identification andtracking of unscheduled trainings.Responsible for release of finished product for sale or to market.Responsible for Approving Standard Operating Procedure and Batch productionrecords, Training modules and validation protocols. # Essential Qualification * MSC (Chemistry) Essential Experience: 15+ Years work experience * Experience with QA measuring and testing equipment * 5 to 8 years' experience as QA Site Head * Knowledge of safety requirements and legal standards * Working knowledge of quality system requirements * Experience with MS Word, Excel, Project Management and Analytics software # Requirements and skill set: * Leadership * Strong written and verbal communication skills * Analytic skills * Collaboration skills * Product management skills * QA process skills * Computer knowledge and skills Reports to: QA Head|Team Size: 6 - 10 ---|--- Name:Designation:|

skills

API, quality, QA Assurance

qualification

MS/M.Sc(Science)