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Thursday, October 23, 2014

Senior Vice President - Quality Assurance

Senior Vice President - Quality Assurance

by Wednesday Coprorate Solutions India Pvt Ltd hiring for a client of Wednesday Corporate Solutions in Ahmedabad
Experience: 18 to 22 yrs.  |  Opening(s): 1Posted on: 21 Oct

Job Description

Job location: Dholka, Ahemdabad

Major Purpose of the Job:

To be second line to Head of Quality and Regulatory and work in close coordination with him.
Should be thoroughly involved in all aspects related to QA, QC and RA.
To ensure successful audits by various international/domestic regulatory bodies and overseas customers.
To ensure cGMP compliance of all manufacturing sites this includes formulation and API.
To review & update quality systems & procedures across all locations.
Responsible for all activities related to testing of in process, finished product and stability and to get their activities performed as per Good Laboratory practices norms.
To perform these activities in time bound manner as per regulatory requirements of different countires and bodies like ICH guidelines, WHO, UKMHRA, TGA, and USFDA etc.
Responsible for overseeing regulatory activities for all markets.
Work closely with International marketing to ensure regulatory compliance, registrations and submission of dossiers in time in alignment with business growth strategy.
Ensure proper implementation of quality management system and automation across the organization in line with corporate policies / guidelines.
To participate various regulatory / customer audits and to ensure the compliance of audit observations.
To authorize SOPs, quality manual, VMP, MMD I, MMD-II, validation and qualification protocols and reports.
Responsible for management deviations, change control, APQR, vendor documents & bath documents.
Build competent QC, QA and Regulatory team which can function in seamless manner with all business units to achieve goals of the company.
Should train the departments and keep then updated on the regulatory norms of pharma industry.

To ensure cGMP related training program as per USFDA, EU, WHO, TGA and other regulatory guidelines, quality management system and applicable various ICH guidelines for manpower associated with warehouse, production, maintenance QA & QC.
To ensure effective budgetary control and cost optimization.
Guide and advise senior management on regulatory and quality issues impacting the organization.
Not Disclosed by Recruiter
Pharma / Biotech / Clinical Research
Production, Manufacturing, Maintenance
Role Category:
Senior Management
Head/VP/GM-Quality Assurance/Quality Control
QA quality assurance qc quality control regulatory affairs Pharma pharmaceutical healthcareregulatory compliance ICH guidelinesusfdacgmp

Company Profile

Wednesday Coprorate Solutions India Pvt Ltd
A professionally managed Management & Human Resources Consultancy. Being an organization with experienced professionals doesn"t stop us from taking new initiatives and accepting challenges. We believe that candidates must match Companies, not just jobs. We are mainly focused into, Engineering & Manufacturing, Automotive, Automobile, Life Sciences & Healthcare (Instrument, Bioscience & Bioprocess) Biotech Research, Hospitality (Hotels & Healthcare) Real Estate, Construction & Infrastructure Development, Telecom, IT & ITES, Power, Oil & Gas Sectors, FMCG & Consumer Durables.

Contact Details
Recruiter Name:
Venugopal K
Contact Company:
Wednesday Coprorate Solutions India Pvt Ltd
109, Dhaskand Street, BR Puram (hopes) COIMBATORE,Tamilnadu,India
Email Address:
Reference Id:

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