QA Manager - Jobs in Amman, Jordan

Job Description

1. JOB PURPOSE:Quality Assurance manager ensures the company quality policy (communicated in SOP?s) is fully and thoroughly implemented in that he/she:úÿÿÿÿÿÿÿÿEnsures planned and systematic operations processes that provide confidence in product suitability for its intended purpose.úÿÿÿÿÿÿÿÿAssures the process of maintaining good manufacturing practices in manufacturing and providing a quality product that is in compliance with its preset specifications.2. KEY ACCOUNTABILITIES:ÿDescriptionÿProduct Release for Shipping?ÿReviews and evaluates all data generated by different operations and quality departments and accordingly release the finished drug product for shipping.?ÿNotifies all involved departments of product rejects in case of non-conforming practices.ÿQuality Policy and Procedures:?ÿDevelops and updates quality assurance policy and systems.ÿManagement:?ÿFacilitate and support quality management in all quality activities?ÿWork with upper management and other department managers with the goal of producing a quality product at the lowest possible cost.?ÿConducts all managerial duties and applying companys policies & long term targets?ÿConducts all administrative duties including regulation of work hours, work shifts, overtime, ?,etc?ÿPerforms periodical employee appraisal for subordinatesÿQuality Awareness and Training?ÿIncrease the QA and QC teams? awareness in the drug manufacturing process by establishing internal and external training programs that shall target critical areas to ensure integration of quality in every production function.?ÿEnsuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.?ÿIdentifying relevant quality-related training needs and delivering trainingÿProblem Solving?ÿInvestigate all manufacturing process problems and product failures to meet with its specifications and manufacturing process requirements at the manufacturing site.?ÿAssist the QA supervisors and officers in solving problems that ariseÿStandard Operating Procedures?ÿGenerate, update and maintain all master SOP?s?ÿEnsuring that distributed SOP?s are always current?ÿEnsuring that all operation governing product manufacture are covered and are being performed in accordance with written approved proceduresAudit?ÿEnsure efficient and objective QA audits that cover the overall product manufacturing process and accordingly perform thorough reviews on all drugs manufacturing orders and packaging standards to assure drug compliance to Current Good Manufacturing Practices.?ÿAs part of the QC raw material check controls assure that API suppliers maintaining a state of compliance to cGMP.?ÿVerify that the technical package/DMFs are up to date and the quality unit issues with suppliers are resolved on a timely manner.?ÿFollow up on previous audits should indicate 100% fulfilments of commitments by suppliers.Product Specifications:?ÿAssessing drug specifications versus in house specificationsReviews and Approvals:?ÿReviews and approves SOP?s, specification sheets and batch records.?ÿReviews and evaluates all data generated by operations and QC departments and accordingly releases finished products through review and approval of analysis reports and COA?s?ÿApproves Installation/Operation and Performance Qualification protocols and reports?ÿReviews and approves Process Validation protocols and reportsData Integrity and Traceability:?ÿEnsures integrity and traceability of all data generatedSafety:?ÿÿMakes sure that required safety instructions are fully implemented.?ÿÿEnsures that all standards, reagents, solvents and other chemicals are properly prepared, maintained and usedScope: The Quality Assurance is responsible for ensuring product quality, suitability and complianceÿtoÿlocal regulatory ÿand international guidelines governing drug manufacture.Related Factors:úÿÿÿÿÿÿÿÿAchieving high standards of quality and compliance and assisting the quality teams to establish their own procedures and to have these procedures be in compliance with current and updated international guidelines governed by the JFDA, SFDA, PIC/s.úÿÿÿÿÿÿÿÿProblem solving methodologies and support quality teams in their assessments and its effect on product quality.úÿÿÿÿÿÿÿÿEffective communications among the quality control and quality assurance managers and with the rest of department?s managers such as regulatory affairs, engineering and maintenance and with all operations managers within the manufacturing site.

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