Quality Assurance Executive

Position : Executive ( Lab QA)Job Location : TarapurJob Profile:

• Preparation and review of department SOPs.
• To ensure GMP compliance in quality control laboratory.
• Handling of deviations and ensure they are investigated and resolved.
• To review and approve changes that potentially impact intermediate or API quality.
• Preparation and review of Risk assessment done associated with the changes proposed or wherever applicable.
• To review Corrective action and preventive action and its effectiveness.
• Out of specification & Out of Trend investigation report review and its closure as per the respective SOPs.
• To review all quality related documents.
• To perform daily QC round to ensure compliance of online activities inline with cGMP and GLP.
• To Review Analytical method validation / Verification and method transfer protocols and reports.
• Reviewing completed batch production and Analytical test data sheets before release of finished products and intermediates and stability data.
• Monthly audit trail verification and Electronic data verification & Random data verification of QC electronic data.
• To review all specifications & testing procedures and test data sheets for Raw materials, Intermediates, Finished products, stability, in process and Pacing materials.
• To ensure quality control specifications and analytical methods are confirming to the latest Pharmacopoeia & customer requirements.
• To review all procedures impacting the quality of intermediates or APIs.
• Ensure that internal audit (self-inspections) is performed and compliance of observations has been investigated and to ensure CAPA implementation and its effectiveness.
• To Ensure that quality related complaints are investigated and resolved.
• To Ensure that there is stability data to support retest or expiry dates and storage condition on APIs & Intermediates where appropriate.
• To perform & review product quality review.
• To Ensure execution of GMP training programs and departmental SOP training.
• To Ensure the job related training for subordinates and ensuring the documentation & job descriptions review.
• To ensure & execute retention samples are handled as per the SOP.
• To ensure stability samples are charged, incubated, withdrawal and tested as per SOP. To ensure & execute the compliance of stability samples as per SOP.
• To review and approve the qualification protocols and reports (DQ, IQ, OQ and PQ).
• Response to Regulatory Affairs Department as applicable and submission of required data.
• Release of API / Intermediate batches.
• To perform and review Incubation, withdrawal and reconciliation activity of stability & Hold time samples in SCM software.
• To Prepare & reviewMonthly and annually schedule of stability & Hold time study samples.
• To maintain & review records of dailymonitoring temperature & humidity of stability chamber.
• To initiate,review of QMS in Track wise software.Any other work allotted by the Head of the departmentExperience : Minimum 4-5 YearsQualification : BSc/ M ScExposure of USFDA/EDQM Inspection.