Head, Quality Assurance, 12-20 years exp, Baddi

Education:

UG - B.Sc - Any Specialization PG - M.Sc - Chemistry

Industry Type:

Pharma/ Biotech/Clinical Research

Functional Area:

Production, Maintenance, Quality

A science post -graduate (Chemistry major) with preferably auditing additional qualification & 12 years of work experience in all areas of quality management in industry segments such as: FMCG, Pharmaceutical, Food & beverage of a mid-sized turnover Company

Should have handled customer, certification & regulatory audits independently & implemented QMS

Should have headed the quality control & Quality Assurance department for the last 4-5 years

KRA s

Conduct regular Quality Review Meeting – update on QMS status

Completion of training on quality systems, Response on Market Complaints, Closure of all Quality documents: CC, Deviation, etc.,

Achieving good score on all customer audits – responding in time & closing open issues

DECISIONS TAKEN

Manpower deployment in Quality Assurance department , Quality policy & quality manual

Training needs identification , CAPA (Corrective Action – Preventive Action) roll out

COMPETENCIES REQUIRED

Coaching & Counseling, Team Work, Communication, Managerial Integrity, Concern for Safety & Environment

Interpersonal Skills, Analytical Thinking & Problem Solving

Job Description

The scope involves to prepare Quality Policy and Quality Plans in various businesses of the Group as well act as interface for statutory agencies.

Role and Responsibilities

1.Quality / System Implementation: Programme finalization and co-ordination to be undertaken, Training of all employees to be done as per schedule, Monitoring progress vis-à-vis target dates, Carrying out the required certification procedures, On-going monitoring and suggesting remedial measures

2.Quality Training Activities: Generating / maintaining quality thrust across all departments and amongst all employees through training programmes, Following up of improvement measures highlighted during training programmes, Introducing latest approaches, advances and thinking in the field

3.Supplier Quality Assurance: Assessment / approval / training / rating to assist the purchase department

Inspection at supplier end, Shifting focus to instill ‘inbuilt quality’ concept in the supplier

4.Rejection Analysis and Corrective Action: Incoming components,Sub-contracted items

5. Responsibility for the following components of Quality System: Annual Product Quality Review, Deviation Control system, Change Control system, OOS and OOT tracking system, Customer Complaints Investigation system, Training system, Specifications and Test methods complete up-dating, Stability study system, Reserve sample storage and tracking, SOP Control system, Pest Control Programme, Validations, Calibrations,

IQ /OQ/PQ IPQA activities Pre-dispatch audit system BMR / BPR control Area / Utilities qualifications Self Inspection Programme / Internal Audit Laying down SLAs to cater internal departments

Functional and administrative authority for the following decisions :

Functional: Manpower deployment in Quality Assurance Department Planning for training gaps identification and training calendar Planning for relevant Quality Assurance systems & procedures Submitting un-biased investigation summary with complete root cause analysis in problematic areas of manufacturing operations

Administrative: Manpower recruitment in quality assurance department Leave & travel sanction of sub-ordinates

Internal Coordination Head – Quality Control Head - Manufacturing Head - Commercial Head - Engineering & Projects Head - HR & Administration CEO

External coordination Customer Representatives Statutory & Regulatory Agencies C.REPORTING RELATIONSHIP TO: Managing Director for all functional matters CEO for all administrative matters

Keywords: QA,Manufacturing,Contract Manufacturing,Health Care,Nutraceuticals, Home care,cGMP,GLP,QA Chemist A pioneer in Contract Manufacturing and Marketing of wide range of health care products including pharmaceuticals, Nutraceuticals personal care, home care and hospital care products for some of the well known companies and Brands Company Name:

A reputed Contract Manufacturing and Marketing company

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