Sr. Executive /Assistant Manager -QA QMS

Sr. Executive /Assistant Manager -QA QMS

Posted by Corporate in Pharma & Life Sciences Sector

Pune

Posted: imported by Jeevika

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Responsible for overall QA compliance activity.QRM & MRM:Assigning the risk assessment number as per requirement.Responsible for reviewing the action plan submitted by all departments and suggesting changes wherever required.Responsible for preparing the minutes of meeting the Quality Review Meeting and Management Review Meeting.Preparation and review of the risk assessment.Preparation of PPT and scheduling Quality Review Meeting and Management Review Meeting.Training and Development:Tracking and maintaining the employees training.Annual cGMP training for new Employee.SOP training evaluation of all departments.Maintain Specimen signature records for all employees.Imparting the training to cross functional teams like Engineering, production, and other departments on the relevant topics.Document control:To prepare controlled copy, uncontrolled copy and other copy as per the requirement and issue to the concern Department / Personnel.Monitor the maintenance of the soft copies, hard copies and obsolete copies of all QMS documents.Regulatory compliance:Single point of Contact for coordinating with regulatory affairs team and cross functional team to facilitate regulatory compliance requirements.Scheduling and tracking regular meetings with RA team to understand the regulatory requirements.Apex documents / SOPs/STPs/Specs:Preparation and review of SOPs, logbooks for QA department.Review of other departments SOPs for correctness.Review of STPs and specifications.Documentation Room:Segregation of documents as per displayed room and update the list of documents on a regular basis.Management and handling of the documents in the documents room.Labeling of the documents/Files/other documents as per requirement.Co-ordination with RA for document sharing.Perform task and activities assigned by HOD whenever required. Skills & traits required: 1. Knowledge of various cGMP and Regulatory requirements related to Validation, Qualification and Calibration. 2. Training on QMS functions / Basic SOPs.3. Training on Validation, Qualification and Calibration SOPs (QA and other departments).4. Awareness on Process especially related to Engineering operation, utilities and Equipment. 5. Good Communication skills with cross functional team.6. Awareness on Software, PLC related to Biotech Equipment’s operations Role: Quality Assurance - Other,Industry Type: Pharmaceutical & Life Sciences,Department: Quality Assurance,Employment Type: Full Time, PermanentRole Category: Quality Assurance - OtherEducationPG: MS/M.Sc(Science) in Any SpecializationKey SkillsSkills highlighted with ‘‘ are preferred keyskillsQMS ProductionChange ControlQMSQuality ManagementQuality AssuranceCapaMarket ComplaintsInvestigationRoot CauseDeviationAbout company M.J. Biopharm is a fully integrated biopharmaceutical company offering human insulin, analogue insulin, GLP1 agents, both as drug substance and formulations ... Company InfoAddress:Plot No, 18, International Biotech Park, Phase II, Raigarh, Maharashtra, IndiaBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. Fraudsters may ask you to pay in the pretext of registration fee, Refundable Fee…Read moreSimilar jobsQuality Assurance ManagerTalentis Hr SolutionsPosted by Talentis Hr SolutionsVapiQA ManagementISO ImplementationISO DocumentationQuality ManagementQuality AssuranceQMS ImplementationAssuranceDocumentationQualityManagementQMSPosted 7 Days AgoExecutive - Quality Assurance (QMS)Bharat Serums and Vaccines3.9738 reviewsMumbai(Ambernath East)CapaQMSChange ControlAssuranceQualityChangeQuality assuranceControlPosted 25 Days AgoSenior Quality Assurance ExecutiveV S International3.7181 reviewsMumbai(Worli)Quality AssuranceSeniorQualityAssurancePosted 13 Days AgoJr Executive / Executive-QMS (OSD)MSN Group3.63438 reviewsHyderabadCapaChange ControlQMSChangeOSDControlPosted 10 Days AgoQuality Assurance ManagerWallace Group3.7318 reviewsDharwadQuality AssuranceQA ManagementQualityAssuranceManagementPosted 6 Days AgoRoles from top companiesAssistant QA Qms ManagerCorporate in Pharma & Life Sciences Sector1-5 Yrs2-6 Lacs P.A.PuneHiring for one of these companies3d agoQuality Assurance ExecutiveLeading Indian MNC in Pharma1-3 Yrs2-5 Lacs P.A.HyderabadHiring for one of these companies3d agoRegister to unlockJobs you might be interested inOfficer /Executive - QA & FDA LicensingPurpleeon Consulting Serv...Posted by Purpleeon Consulting Serv...PunePosted 24 Days AgoExecutive - Quality Assurance (QMS)Bharat Serums and Vaccine...3.9738 reviewsMumbai(Ambernath East)Posted 25 Days AgoQuality Assurance Executive - QMSOptrascan4.38 reviewsPunePosted 4 Days AgoSr. Executive - QASymphony HrPosted by Symphoni HrMumbai (All Areas)(Tarapur)Posted 10 Days AgoExecutive - QA ValidationBharat Serums and Vaccine...3.9738 reviewsMumbai(Ambernath East)Posted 25 Days AgoReviewsView all375 employee reviews4.0rated by Apprentice Trainee in PuneLikes"I enjoyed working with experienced colleagues and learning about preventive maintenance, utility systems, and equipment troubleshooting. The work environment encouraged continuous learning, and I gained valuable hands-on experience that has helped me grow professionally."DislikesOverall, I had a positive experience at MJ Biopharm. If I had to mention one area for improvement, it would be that there were limited opportunities to work on a wider variety of engineering projects during my role. However, I understand that every organization has its own priorities, and I used the experience to strengthen my technical skills and learn from experienced team members."Read full reviewPowered bySalary insightsAssistant Manager - QA in MJ Biopharm typically earns between₹10.5 - ₹11.6 L/yrSee detailed salary breakupPowered byBenefits & PerksView all29 employees reported these benefitsTransport / Travel SupportHealth & Wellness SupportFree MealLearning & Development SupportPowered by

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