Assistant Manager Validation

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4 – 9 Years



Job Description

Job Purpose:
The incumbent is accountable for the coordination and execution of validations and related activities at Nasik Site.
Key responsibilities:
Review and maintenance of the site validation master plan
Review and maintenance of the validation & re qualifications schedule at site
Coordination of preparation of user requirement specifications and carry out factory acceptance tests and site acceptance tests of new equipment as & when required.
Coordination of design, installation operation and performance qualifications across the site
Ensures compliance to all related audit observations in a time bound manner
Preparation of validation plans, protocols, reports and validation summary report
Preparation & review of validation SOPs
Providing support for equipment qualification /process validation across the site in coordination with QC, PR&D and respective department
Take care of complaints handling as and when required
Conduct gap analysis against QMS documents as per requirement
Preparation & review of SOP for validation/ Qualification
Execution of validations triggered through a change control process
Active participation during Root Cause Analysis as & when required
Active participation in GPS activity at the site
Ensure that all risks for department are identified, assesses and mitigated in accordance with Risk Management principle.
Minimum Requirements
Masters in Science / Pharmacy
4+ years experience in Pharmaceutical Plant, Process, Validation and Plant Maintenance
Sound knowledge of preparation of SOPs
Proficiency in conducting audits
Knowledge of Regulatory, QMS and EHS regulations
Excellent communication skills and the ability to build relationships at all levels and across functions.
Proficiency in use of computer software (Word, Excel, Power Point)

Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other


Desired Profile

Education:UG -Any Graduate – Any Specialization, Graduation Not Required
PG – Any Postgraduate – Any Specialization, Post Graduation Not Required
Doctorate – Any Doctorate – Any Specialization, Doctorate Not Required

Company Profile

Greetings from GSK Pharmaceuticals Ltd.
GSK is one of the world’s leading research based pharmaceutical and healthcare companies.
Our Nasik facility manufactures Solid Dose (Tablets) Ointments and creams. It has a committed workforce of nearly 850. The plant has a capacity of manufacturing 8 billion units annually.
Nasik plant won 2nd place in Best Safety Practices Awards 2015 for its best practice on ‘ZAPs – Building culture of Zero Accident by engaging employees on safety initiatives’
It was Ranked 2nd in the Pharma sector in ‘Business World – Great Expectations’ in the ‘Most Respected Companies 2016’ list. Won The Economic Times Supply Chain Award 2016 for exemplary supply chain management and logistics and Bronze award in ‘disease awareness campaign’ (congenital hypothyroidism) at Big Bang Awards 2014.

GSK intends to create an environment where development of staff is key, where people delight in where they work and are inspired to deliver their best. A modern way of working will be created where people are valued for the contribution they make and where their career aspirations can be met.
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Contact Details

Recruiter Name:HR

Contact Company:GlaxoSmithKline Pharmaceuticals Limited

Telephone:Not Mentioned

Source by naukri…