Quality Assurance Operations Manager

Company Description

EQL Pharma

Role Description

Key Roles and Responsibilities

1. Quality Management System :

i ) SOP and Document Management

: Ensure SOPs are prepared, reviewed, approved and Implemented for all below listed activities managed by Operational Quality Organisation.

ii ) Create, Manages and archive all quality documents and records in relevant quality management support systems in soft and hard copy form as required.

2 ) Change Control Management :

i } Change Control Board Lead :

Act as a Change control Board lead and drive the change controls are logged and assessed adequately and implemented in time.

ii ) External CC from CMOs :

Receive Change Control documents from Suppliers / CMOs, have preliminary check and log in to system in consultation with QRM and ensure it is adequately assessed and implemented in time.

iii ) Internal CC from EQL CFT

: Receive Change Control documents from CFT, have preliminary check and log in to system in consultation with respective CFT and ensure it is adequately assessed and implemented in time.

iv ) QRM Support :

Seek QRM Support if required to get the documents from CMO and expedite the CC approval process

v ) Q.P Approval :

Ensure the change controls are notified to QP for final evaluation and feedback and approved finally.

3 ) Deviation Management :

i ) External CC from CMOs :

Receive Deviation documents from Suppliers / CMOs, have preliminary check and log in to system in consultation with QRM and ensure it is adequately investigted, Root cause and CAPA identified and implemented in time

ii ) Internal CC from EQL CFT :

Receive Deviation documents from CFT, have preliminary check and log in to system in consultation with respective CFT and ensure it is adequately investigted, Root cause and CAPA identified and and implemented in time.

iii) QRM Support :

Seek QRM Support if required to get the investigation done adequately & support to documents from CMO and expedite the CC approval process

iv ) Q.P Approval :

Ensure the Deviations are notified to QP for final evaluation and feedback and approved finally.

4.) Complaint Management

i ) Complaint Investgation at CMO

: Receive Complaints from Market / QP /Suppliers / CMOs, have preliminary check and log in to system in consultation with QRM and ensure it is adequately investigted, Root cause and CAPA identified and implemented in time.   

ii )QRM Support :

Seek QRM Support if required to get the complaint investigation done adequately & support to documents from CMO and expedite the CC approval process

iii ) Q.P Approval :

Ensure the Complaint final investigation reports are notified to QP for final evaluation and feedback and approved finally.  

5 ) PQR Review and Approval

i )

Receive PQR from CMOs for the EQL scope products and ensure review completed in time.

ii )

Ensure the review covers below key aspects but limited to.... 

a.) Verify the consistency and appropriateness of a product's manufacturing process.

b.) Assess the suitability of current material and product specifications.

Identify trends and potential areas for product and process improvement.

c.) Determine the process capability and need for process revalidation or changes to specifications or procedures.

d.) Indentify scope for improvements and recommendation made to improved.

iii ) Q.P Approval :

Ensure the PQR final reports are notified to QP for final evaluation, feedback and approved finally.

7 ) Batch Document Review and Release process management.

i ) Ensure batch release SOP is prepared and impleted after training and followed.

Ii ) Receive the batch release documents from CMOs and perform the review as per the batch release check list.

iii ) Notify to CMO if any gaps identified and get it addressed adequately and timely.

iv ) Co-ordinate with Import testing las and get the resuts and verify with CMO release test COA and esure if any OOS / OOT investigated at both labs and addressed adequately before sending to QP.

v ) Archival of batch release documents in folders.

iv ) Q.P Approval & Batch Release :

Ensure the final batch release certificate / reports are notified to QP for final evaluation, feedback and approved and batch released by QP.

8. ) Risk Management / Assessments and Control

i )

Ensure Risk managemt system is implemented and follwed at EQL and the risk Assessment including the below but not limited to…

a. ) Product Quality Risk Assessment

- Nitrosamine Risk Assessment,

- Elemental impurity Risk Assessment

b.) Quality Compliance Risk Assessments :

This includes any compliance risks identified during Audit to assess impact to product.

Qualifications

and Experience:

Bachelor or Masters Degree in Pharmacy or Master in Science, Quality Assurance/Technical.

10+ years experience in 
Quality Assurance Handling QMS Section

or 

Combination of Quality Assurance and Quality Control

Knowledge of cGMP, Quality Systems, regulations and the pharmaceutical manufacturing, supply chain environment.

Understanding of E.U GMP, Local GMP regulations, Standards of Pharmacopeia, WHO and ICH guidelines, ISO etc.

Leadership Capabilities

Passion for Customers

Thinks Strategically

Acts Decisively

Driving Performance

Works Collaboratively

Develops people and organization

Core Capabilities

Business acumen

Process Management

Stakeholder Management

Time management

Team player

Strong problem solving skills

Strong negotiating / influencing skills

Ability to work independently under his/her own initiative