Head Quality Assurance -Goa Plant - MERCK LTD

Job Description

 TECHNICAL AND JOB SPECIFIC

•You are responsible for Benchmarking of the Quality Assurance & Quality Control

• You are responsible for Benchmarking of the Statutory (State FDA) compliance.

•You are responsible for the improvement of the productivity in Quality Control Laboratory.

•You are responsible for the follow-up and the control of the budget (headcount, invest, expense).

•You are responsible for distributing the results obtained in the form of Quality Metrics, Statutory metrics and Key Performance Indicators to Head, CQA, Mumbai.

•You are responsible for the modifications of the procedures following the action plans of Supplier Audits, Audits by Corporate Quality Assurance, Geneva and Standards issued by Quality management, Technical Operations, Geneva and inspections by Local FDA.

•You are required to take part in the realization of the program of internal audits.

•You are guaranteeing application of rules and health, safety, industrial hygiene and environment.

You are responsible as system owner to the following systems-

I. QUALITY & COMPLIANCE

A] Quality Systems : You need to ensure that the requirements of operations and logistics dept are met in a constant concern of Quality and Compliance, productivity and customer service.

You will ensure a low cycle time for the materials & products analyzed in the QC laboratory by timely validation of results and incident investigations in accordance with the quality procedures.

As a system owner for Deviation raising you have the responsibility to ensure that the results of quality control tests are systematically recorded and documented according to the applicable procedure and in compliance to the standards set and deviations are documented and closed.

As a system owner for Complaints raising you have the responsibility to ensure that the timely investigations are conducted & systematically recorded in Track Wise (software used for complaint management ) and documented according to the applicable procedure and in compliance to the standards set and complaint trending and corrective actions are taken.

As a system owner for Change controls raising you have the responsibility to ensure that the proposals are systematically recorded and evaluated according to the applicable procedure and in compliance to the standards set and impact assessment is thorough.

As a system owner for Out of Specification results, you will evaluate systematically results of quality control tests. Whenever out of specification & out of trend are found, they must be documented according to established standards & deviations.

B] Quality Operations :

1.Chemical and Instrumental Analysis

•To guide laboratory chemists in trouble shooting during analysis of raw materials, bulk products & finished product.

•Monitoring of reagent management and volumetric solutions management.

•Monitoring of reference standards, internal standards management.

•Review / revision / training / implementation of Merck / pharmacopoeial / local regulatory policies & SOP’s pertaining to above.

2 Microbiological Analysis :

•To guide microbiological chemist for analysis of raw materials, packaging materials & finished product, raw data checking and report checking.

•Monitoring of media preparation management and pathogens subculture management.

•Water reports review of chemical, microbiological & operational parameters.

•Review of trends & summary reports for environment & water.

•Review / revision / training / implementation of Merck / pharmacopoeial / local regulatory policies & SOP’s pertaining to above.

•Ensuring current specifications & methods are available for the above

3.Calibration and Qualificaitons :

•Ensuring calibration of laboratory equipment like HPLC, UV-Vis Spectrophotometer, analytical balances, Dissolution test apparatus, tablet friability tester, disintegration test apparatus etc. Auditing of dissolution / reference standards, (including the relevant CoA’s and validity)

•Ensuring that the cool room facilities of stores are calibrated, mapped, qualified and validated.

4.Validation :

•Checking and signing of validation protocols and reports of process validation, cleaning validation as well as environment monitoring.

•Drawing validation protocols and tests and executing them

5.In-process monitoring :

•Applicable in-process audits of warehouse, Soft gelatin capsules / Injectable and Chemical manufacturing and packaging area.

•Review / revision / training / implementation of Merck / pharmacopoeial / local regulatory policies & SOP’s pertaining to above including sampling procedures, storage conditions, label control, FEFO.

•Retained / control sample storage & records monitoring for raw materials & finished products

6. Annual product review :

•Ensuring on time completion of annual product review of all products with statistical control charting and process capability. Devising action plans out of the APR.

7.Specification review :

•Conducting training and effective implementation of the updated revised specification to avoid failures.

8.Dispositions :

You will inform all complaints to

•Site Manager

•Head, CQA Mumbai

You will inform all critical / major deviations / OOS/Change controls to

•Site Manager

•Head, CQA Mumbai

You will inform all material /products rejection proposals to

•Site Manager

•Head, CQA Mumbai

C] Compliance:

You are responsible for

1. Audits :

•To be always prepared for state FDA inspections:

•Prepare for and face the Merck international audits and prepare the CAPA for the same.

•Maintain the site with no significant observations.

•Review of internal audit reports of the site

2. Management action plan:

•Ensuring on time completion of management action plan on complaints , non-conformances / deviations observed in laboratory / process by taking preventive measures to avoid further non-conformances and deviations.

•To reduce complaints, deviations / non-conformances in the laboratory / process.

•Effective closures of the complaints, non conformances / deviations in laboratory.

II. PERSONNEL TRAINING:

You are responsible as a system owner for training so as to ensure the Technical expertise, Training & Qualification and Monitoring of performance of the personnel at site. You ensure this by

•Familiarizing the personnel with requirements of FDA

•GMP, skill based training.

•Performing gap analysis of the jobholders profile and job specifications, deviation trends of QA/Q.C personnel.

•Developing training program for the QA / QC personnel to become qualified in specific areas

•Monitoring the effectiveness of training and providing feedback for continuous improvement

•Setting performance indicators and conducting performance appraisals of QA / QC personnel.

III. SITE STORES :

You will prepare the warehouse personnel for state FDA / External audit.

You will implement Good warehousing practice based on Corporate guidelines, WHO and Drugs & Cosmetics Act & Rules.

IV. STATUTORY COMPLIANCE & LICENSE MANAGEMENT:

To assist Manager, Quality Control in ensuring that all manufacturing licenses are current and valid. This will include the co-ordination of activities related to renewal of license &/or fresh application for the same.

You will be responsible for response to queries raised by the health authorities.

You will be responsible for applications and renewals of WHO GMP Certiifates, CoPP, Productions certificates, marketing certificates, No conviction certificates, Free sale certificates for the Goa site.

You will establish rapport with regulatory officials within FDA Goa.

V. COMMUNICATION:

You have the responsibility to ensure that regular written communication between Merck and the various external and internal services & customers concerned takes place clearly and efficiently.

VI. WORK ORGANIZATION:

You need to ensure that department provides the best service in term of quality and speed of completion of the work, within the allocated budget.

You will put forward and set up measures intended to improve the productivity and to reduce the costs of control and compliance.

VIII. Conformity:

You have the responsibility to ensure that the Health and Safety Rules are complied in all the fields of your activity.

You have the responsibility to ensure you that the activities performed at site are controlled in strict conformity with the GMP, and specifications.

MANAGEMENT RESPONSIBILITIES

Human Resources

You are required to take part in the recruitment and the training of the new employees.

You need to propose a plan of training for the QA / QC team.

You need to follow and evaluate the performances of the Quality Department

You are responsible for self development and training

Budget Responsibilities

You are responsible for the budget of the QA / QC dept

You must evaluate your needs and propose an operational budget.

You need to manage within operational budget.

Desired Candidate Profile

Required at least 15 years in multinational or large Indian Pharmaceutical company with Quality Assurance ,Quality Control and Injectable experiance.  

Company Profile

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