Quality Assurance Manager Clinical Operation Bangalore : Clinigene International Ltd

[muthukalee]

Department : Quality Assurance

Position : Deputy Manager – Quality Assurance (Clinical Operations)

Qualification : Bachelors in Life Sciences

Experience : 4 - 6 years.

No. of Position : 1

Location : Bangalore

Job Description :
* Responsible for overall Quality System in Clinical Operations department.
* Planning and scheduling of relevant department activity – e.g. audit, review
* Document preparation, control and review including change control
* Document control - ensuring that document approvals are managed in an efficient and effective manner and that document cross-references are accurate and traceable, to group company decisions and external regulations
* Review of documents to reflect current practices of the department
* Issue of Quality systems documents.
* Ensuring meticulous records of document status, outstanding change controls
* Driving education of document control across the organization, both inside the QA and clinical operations functions.
* Training of personnel on Quality systems documents in clinical operations.
* Approval of Quality Management System documents in the Department.
* Change control handling
* Control of sponsor documents’– review, issue, usage

Desired Profile :
* Should have excellent working knowledge of ICH/GCP guidelines and other regulatory guidelines relevant to clinical research in India and other countries.
* Should have technical skills in terms of the requirements of the Quality Management System in GCP
* Should be abreast with current industry trends / compliance
* Must have extensive experience in clinical quality assurance working at the highest level of competency

Apply : careers@clinigeneintl.com

About us :
Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP (College of American Pathologists) accredited Central Laboratory. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

Contact us:
Clinigene International Limited
"Clinigene House",
Tower 1, Semicon Park
Electronic City, Phase II,
Hosur Road, Bangalore - 560100, India
http://www.clinigeneintl.com/

[Guest-IJT]

Name : AVINASH ADINATH CHOUKATE
Email : avinashchoukate AT yahoo.com
Designation / Skillset : Dy.Manager QA

Resume :
Managerial assignments in Quality Assurance / Control with an organisation of repute
CAREER PRÉCIS
- Over 15 years’ experience in the areas of Quality Assurance, Quality Control, Vendor Management and Team Management.
- Adept at carrying out various tests and inspection for various processes and checking the quality standards of final goods at suppliers’ end.
- Through knowledge of Detail Layout Inspection of Castings & Forgings.
- Through knowledge of MRP & SAP R3 System (Quality module).
- Knowledge of ISO 9000, TS 16949
- Through knowledge of DIN, N, JIS, JASO, IS Standards, APQP, PPAP, FMEA and Control Plan.
- An enterprising leader with proven abilities in leading teams towards the achievement of organisational goals and industry best practices.
- Excellent interpersonal, analytical and troubleshooting skills with ability to synthesize complex information and communicate technical issues with skills in pioneering practical solutions to difficult problems.
CAREER CONTOUR
Associated with M/s Atul Auto Ltd, Pune since Sept.10 as a Dy.Manager QA in Engine Group
- Joined M/S CTR Manufacturing Industries Ltd, Pune, in Jan ’09 as Asst. Manager QC.(In process & Vendor Quality) and rose to the post of Dy.Manager (In process & Vendor Quality ) Period from Jan 09 to Aug.10
- Joined M/S Force Motors Ltd., in Feb ’94 as Jr.Engineer and rose to the post of Sr.Engineer (Vendor Quality) Period Feb 94 to Dec 08
The Accountabilities :
Quality Assurance
- Defining & implementing the quality standards and structured processes / quality plans for various production operations.
- Monitoring and optimising the manufacturing processes & troubleshooting problems in coordination with other departments for new product development & improving efficiency.
- Focussing on optimisation of process parameters; initiating process improvements for achieving bottom line objectives & productivity targets..
- Reviewing quality problems of internal costumers, organising daily work / assignment to Inspectors / Engineers and handling performance review of Inspectors & Engineers.
QMS Implementation & Compliance
- Developing & implementing policies, guidelines& procedures to establish /maintain high quality standards in compliance with statutory norms.
- Conducting regular internal audits and reviews at supplier location to ensure adherence to pre-set norms; ensure conformance across all functions and processes.
- Assessing quality performance in production areas along with the analysis of departmental production goals verses quality and cost objectives.
Vendor Management
- Handling independently all responsibilities & functions of Vendor Quality Department by inspecting approx. 210 Nos. of items from around 73 Vendors.
- Conducting SQIP Audits of Suppliers / Quality Audits of Self Certified Suppliers.(Once / Year for product audits & Once / 3 Years for suppliers audit)
- Performing inspection of Proprietary, Machined, Pressed, Rubber and Fabricated Items.
- Preparing the documentation of ISO 9000 / QS 16949, Monthly Business Performance Review Reports, Inspection Plan, Control Chart, Pareto Analysis and SQC Work.
Team Management
- Leading, training, mentoring & monitoring the performance of team members to ensure efficiency in process operations and meeting of individual & group targets.
- Creating and sustaining a dynamic environment that fosters development opportunities and motivates high performance amongst team members.
Significant Milestones :
- Successfully developed :
- P/Up Hold Assembly & A/R Body with in-stage & final inspection plan.
- Crank Case Assembly Machined with inspection plan & suggestions to made fixture fool proof.
- Effectively resolved continuous problem of spot dents on skin panel results in heavy rejection after painting was eliminated by implementing spot welding circular copper disc.
- Expert in the inspection of Fuel Injection Pumps & Injectors, Piston, Piston rings, Crank shafts, Con Rods, Crank Case Assy’s, Cy.Heads & Blocks.
- Thorough knowledge of the inspection of tangential loads of piston rings, twist & bend of con rod, throw of crank shaft, performance checking of FIP & Injectors.
- Instrumental in putting forth suggestion for Offloading Painting for Volumous Items results in less handling, time saving, improvement in quality and cost reduction.
- Stellar in completing Outdoor Training of Magnetic Particle which enables for self NDT Testing & Fast Inward Material Clearance, resulted in inventory control.
- Distinction of handling New-Project - MINIFOUR-Model - Castings, Forgings & Machined items of an Engine developed with rigorous inspection, suggestions in design & follow up with suppliers & R&D.
- Played a vital role in suggesting approx. 8 to 10 Non Moving Items consumed by small rework / alteration which resulted in cost saving.
- Analysis of customers complaints & effectively corrective action implementation results in increase of product customer base.
SCHOLASTICS
- Certified Six Sigma Black Belt (By Quality Environment Affiliated to ISRO, Dept Of Space, Govt of India)
- Diploma in Mechanical Engineering(Production Tech.) from P.D.V.V.P. Polytechnic, A. Nagar (Board of Technical Exam, Mumbai in 1993.
- Certified Magnetic Particle Testing Level II Engineer.
IT SKILLS : Well versed with Windows, MS-Office (Excel, Word & PowerPoint), DOS and Internet Applications.
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4179807
Date & Time : 27th May 2011 7:44 AM (UTC)
IP Address : 123.236.166.198
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Predicted Country : India