• Global Dent Aids Pvt. Ltd.
  • Noida, Greater Noida, Uttar Pradesh
  • Save Job
  • 10 - 12 Years
  • Posted : above 1 month

Job Description:

Job Description

Assistant Manager Compliance & Validation has a pivotal role in implementing policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team involved in validations This position has accountability for Regulatory, Quality and Compliance issues, including local regulatory issues, risk management issues, training and development, product compliance, special handling regulations, and related information technology requirements RESPONSIBILITIES / ACCOUNTABILITIES

 In charge of development and management of the company’s GMP & QMS

 Trains teammates on GMP in regard to the manufacturing, packing & distribution from site in order to meet local FDA, company and other regulatory requirements

 Provides validation expertise and authoring of process and system validations Provides support and oversight for local quality systems and environmental monitoring

 Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices

 Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results

 Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports

 Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs

 Leads team involved in validation who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements

 Provide direction and assign work to Validations Specialists to meet goals and timings

 Coordinates prioritization of activities with area management

 Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions

 Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality

 Participates in regulatory and customer activities

 Collaborates with functional departments to resolve issues

 Conduct periodic Management Reviews of the suitability and effectiveness of the Quality System

 Develops, implements, and monitors Quality System policies and procedures to assure products manufactured, packed and stored in line with Company, Cosmetics & Drugs and local Regulatory requirements

 Facilitates internal and external audits processes and procedures

 Leads teammates and resources involved in legal regulatory compliance issues, regulation interpretation, and interaction with outside parties Coordinate with Company regulatory & Local FDA team

 Participates in FDA and other regulatory body audit/meeting preparations May act as regulatory representative at FDA meetings, responses to agency inspections and audits and conducts follow-up activities; participates as a liaison with external Quality System auditors and Regulatory

 Be responsible for follow up all actions from Quality Deviation and GMP corrective action

 Supervise and to be back up of all QA Compliance staff to release products for sale

 Collect all data relate to quality performance for reviewing of day to day quality and Annual Product Quality Review


 Degree qualified preferably in Pharmacy/Chemistry

 Degree in Quality Management / Post Graduation Pharmacy/Chemistry

 is an advantage

 Proven expertise and skills in Health Care product quality management techniques, processes and systems

 Familiarity with Pharmaceutical GMP Standards

 Fluency in English is essential advantageous / essential


 Minimum 10 -12 years experience in Quality Assurance / Compliance of manufacturing site and / or technical centre preferably within a multinational Health/ Pharma companies  Commercial acumen Understands the impact of Supply decisions on business profitability  Strong track record of delivery is critical  People management Proven experience in leading managing and developing teams, able to influence people of all levels  High level of knowledge of a QC/QA process or system  Flexibility in thinking and pragmatic problem-solving skills

 Knowledge of at least local legislation to ensure that the com

Proven experience in project management  In depth knowledge of Schedule M, GMP & GLP Standards

 Certified Internal Auditor

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging, Quality/Process Control
Role : QA/QC,Quality Control,Compliance Management
Salary : Not Mentioned
Deadline : 19th Nov 2019

Key Skills:

Company Profile:

Not Mentioned

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