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Quality Assurance Jobs in Sonipat,Haridwar,Kashipur - BalaJi Manpower & Management

Quality Assurance
BalaJi Manpower & Management
29999 - 49999 Per Month
BalaJi Manpower & Management
Last Date 25 Jun 2018

BalaJi Manpower & Management - Job Details

Date of posting: 26 Apr 18

JOB SUMMARY

  • You are responsible for ensuring that the quality  of drugs being manufactured meet prescribed quality levels, Specific duties of a pharmaceutical quality assurance professional include analyzing  the production process of pharmaceuticals, finding out area where errors prevail, minutely observing every activity and their drugs being manufactured or packed for visible defects,  testing the drugs by various methods in order to check their characteristics, nothing down observations gathered from the quality control process, accepting or rejecting lots of drugs on the basis of samples drawn, contributing in implementing quality control programs, giving inputs in preparing training manuals and quality guidelines for production and quality control of pharmaceuticals.
  • Shop Floor and Manufacturing Activities.
  • Monitoring shop floor activities and work allocation of sub-ordinates.
  • Effective planning for optimizing utilization of man powers.
  • Implementing system, process &technical capability enhancement and conducting Failure investigation.
  • Line clearance and In process checks during dispensing, manufacturing and packing in pharmaceutical dosage forms.
  • Responsible for Review and closure of batch records as BMR/BPR.
  • Organizing Training Programs.               
  • To check cGMP aspects in departments and follow up.    
  • Coordination with various departments for quality and production.
  • To ensure the availability of current documents in each departments.
  • Maintaining documents for audit purpose.
  • Handling, implementing and closing of Deviation and change controls.
  • Handling of Incident/Investigation, Market Complaint and CAPA.
  • Preparation & Review of APR/APQR.
  • Issue of batch records to production departments.
  • Review of Draft BMR/BPR.
  • Ensuring compliance of audit observations
  • Part of self- Auditing team.
  • Impart Role in External Audit Preparation & Its Compliance.
  • Trouble shooting at Manufacturing Stage.
  • Review of Shop floor observations - Category Wise (Pareto Tool Analysis).
  • Review of Equipment Qualification/Risk Assessment.
  • Review of Raw Material/Packing Material Availability/ Standardization of Vendor.
  • Focus on Investigation Rationale - To reduce Batch Failure.
  • Review of Rejection Analysis stage –wise-through RCA/ Fishbone/Ishikawa Diagram.
  • Review of AQL Attribute – for Bulk Approval.
  • Review of Monthly Report – focus on how to improve Quality Index.
  • Function and Q.M.S. group activities.
Quality System Review –
  • Review of 100 % SOPs/CQ Guideline/CQ-Directive/Document-GAPs (System Harmonization).
  • Review of Deviation/ Change Control Management.
  • Review of CAPA.-Local/Global Based/Effectiveness of CAPA.
  • Review of Market Complaints/Investigation (Focus on How to reduce the market complaints and improve Quality Index.
  • Review of Product Assessment/ Process Validation/Cleaning Validation/Hold-Time Study.
  • Review of Technology Transfer Document- PDR/PIR/MPS/MFC/MF/Spec/Analytical Method/Risk Assessment
  • Review of APR/Stability/Repeat Analysis.
  • Review of Inspection-Routine inspection/Self Inspection/CC Quality/CC Safety Inspection.
  • Performing Unit Operation as per SOP/GAP Analysis/System improvement.
  • Quality control System Review
  • Review of OOS, Lab Incident, Lab Compliance- Non conformities/observations, raw data review, GLP Management.
  • Review of 21 CFR Part 11 Compliance in QC area- Audit Trail review.
  • Review and focus over Data integrity Compliance in QC area.
  • Review of Microbiology Section Management.
  • Review of stability section Management, Chemical management, Lab Safety management.
Other System Review –
  • Review /Comparison of GMP Trends Verses Location.
  • Review / Comparison of Warning Letter Verses Location.
  • Review of System Discrepancies in location and compare/harmonize with other locations.
  • Review /Continuous Monitoring of Largest Selling Product - Products/Benchmark Products
  • Review of Hurdles in Productivity
Training
  • The manufacturer should provide training in accordance with a written programmed for all personnel whose duties take them into manufacturing areas or into control laboratories (including the technical, maintenance and cleaning personnel) and for other personnel as required.
  • Besides basic training on the theory and practice of GMP, newly recruited personnel should receive training appropriate to the duties assigned to them. 
  • Continuing training should also be given, and its practical effectiveness periodically assessed. 
  • Approved training programmers should be available.
  • Training records should be kept.
  • Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training
  • The concept of quality assurance and all the measures which aid its understanding and implementation should be fully discussed during the training sessions.
  •  Visitors or untrained personnel should preferably not be taken into the production and quality control areas. 
  • If this is unavoidable, they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. 
  • They should be closely supervised.
  • Consultant and contract staff should be qualified for the services they provide. Evidence of this should be included in the training records.
 AUDIT AND COMPLAINTS/ COMPLIANCE & QMS 
  • Have deeply traversed all the aspects of compliance like Document Review, Review of different protocols and SOP’s for their righteousness and assessment of their fit as per the process and product.
  • Actively participated in internal auditing process and efficiently
  • Handling of Incident, Non-conformance (NCR) and Unforeseen deviations.
  • Documentation and Data control. 
  • Execution and completion of Error corrections carried out the GAP Analysis, subsequently filling of those gaps and maintaining the process and document compliance.
  • Monitoring all calibration activities and review of related documents.
  • Execution of Self inspection/ Internal Audit.
  • Coordination with Training Programme.
  • Handling of Change Control Proposals.

Job Summary

Job Type : Full Time
Job Role : Others
Job Category : Diploma,BSc/BCA/BBM,Others
Hiring Process : Face to Face Interview, Telephonic Interview
Who can apply : Freshers

About BalaJi Manpower & Management

We are leading a excellent consultancy at Uttarakhand .
This posting is done directly & exclusively on Freshersworld.com. We do not entertain any unsolicited calls or enquiries from any consultants, other portals or TPOs. Notice: This recruitment is FREE. if the recruiter charges any fees, please write us info@freshersworld.com

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BalaJi Manpower & Management recruiting Quality Assurance candidates nearby Sonipat, Kashipur, Rudrapur, Haridwar.BalaJi Manpower & Management vacancies for Quality Assurance is recruited through Written-test, Face to Face Interview etc.
BalaJi Manpower & Management Company recruits a lot of candidates every year based on the skills . The candidates with M.Pharm, BSc, BE/B.Tech, B.F.Sc(Fisheries), PG Diploma, MSc, Diploma, B.Pharm, M.F.Sc(Fisheries) are selected to full fill the vacancies in Others job field. The candidates nearby Sonipat, Kashipur, Rudrapur, Haridwar can apply for Quality Assurance position in BalaJi Manpower & Management. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the BalaJi Manpower & Management recruitment, candidates are mostly chosen for the department of Others . To learn more about the current jobs and other details, it is better to go through official site of BalaJi Manpower & Management and Freshersworld. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Freshersworld is a leading employment portal that researches the official site of BalaJi Manpower & Management and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in BalaJi Manpower & Management and near your city and get a secured career.