Senior QA Executive
Our client is a biopharmaceutical company. They are currently seeking for Senior QA Executive.
The role of the Senior QA Executive includes:
- Support all qualification/validation activities by performing review of protocols, qualification / validation dossiers (e.g., GMP Risk Assessments, User Requirement Specifications, Design Specifications, Functional Specifications, Installation Qualification, Operational Qualification, Performance Qualification, including the respective protocols and reports, including supporting site discrepancies, deviations, investigation and closure) according to harmonized regulatory qualification rules / guidelines and obtain the approval of the files with the heads of the site.
- Evaluate the requirement for qualification / validation tests needed for particular process or equipment / instrument and update the validation/qualification monitoring file.
- Management of internal and external audits of site.
- Perform and document internal audits and other quality assurance activities to ensure readiness on international standards certification audits and GMP regulatory inspection.
- Create, review work instructions and standard operating procedures, devise sampling procedures and directions for recording and reporting quality data.
- Support on the review of generated reports for in-placed monitoring regime for Water, Carbon Dioxide, Compressed Air, and external storage.
- Support on performing audit trail review on completed batches prior to batch release.
- Manage customer queries, customer satisfaction surveys, supplier evaluation, and other quality / regulatory purpose documentation requests.
- Support to prepare documents and questionnaires needed by customers for regulatory submissions and attend to customers / regulatory-related queries in a timely manner.
- Support in the investigation of customer complaints and non-conformance issues.
- Prepare annual product quality review (APQR) report based on the consolidated data from all the batches produced.
- Assist Quality Manager in the management of inspection readiness in ISO 9001, FSSC 22000, ISO 22000, Halal, Kosher and GMP across site, including consolidation and follow-ups of responses to audit findings.
- Management of supplier qualification and ensure compliance to regulatory and international standards, including updates of approved vendor/supplier master list.
- Conduct / perform training to employees to improve GMP / international standards certification awareness and compliance.
- Support on performing SAP certificate profile creation, inspection plan creation (method, specification and characteristics), blocking and unblocking of goods, and other Quality T-code SAP functions.
- Conduct QA verification relating to the release of finished goods and inspection of incoming materials received on the external warehouse.
- Perform any other duties and responsibilities as assigned by the Quality Manager whenever necessary.
Job Requirement:
- At least 5 years related working experience.
- GMP Background.
- Possess internal audit experience.
- Diploma or Bachelor's Degree in Pharmacy, Chemistry, Life Science or any science related course.
Interested candidates, please sendyour detailed resume stating Past Employments, including Reasons of Leaving, LastDrawn Salary for the most recent 2 positions (breakdown of basic salary,allowance, bonuses etc), Expected Basic Salary and availability.
WE REGRET TOINFORM THAT ONLY SHORTLISTED CANDIDATES WILL BE NOTIFIED
Manfield Employment Services Pte Ltd (Lic. No: 95C2823)
Posting Personnel: Win Hui
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