We are urgently looking for GM -DQA For a renowned Pharma Co. to be based at Navi Mumbai location.
The Co a leading player in the discovery of new molecules both NCEs (new chemical
entity) and NBEs (new biological entity) with eight molecules in various stages
of clinical development. The company has a significant presence in branded
generics markets across emerging economies including India. The subsidiary also markets APIs to regulated and semi-regulated countries.
The Co. employs nearly 10,000 people in over 80 countries and with its twelve
manufacturing facilities in four countries, five R&D centers and Front-ends
in US, EU, India, Brazil and other markets worldwide, is well placed
on the road of growth and is exceedingly well prepared to take the completion
head-on.
1,
POSITION DESCRIPTION
Emp ID
|
--
|
Name
|
--
|
Role / Position
Title
|
GM
|
Grade
|
CM1
|
Cadre
|
Services
|
Department/Function
|
QA
|
Country
|
India
|
Location
|
Navi Mumbai
|
Division
|
--
|
SBU
|
Quality
|
Appraiser
|
Head
of Global Quality
|
Reviewer
|
CMD
|
** fill by person
2,
POSITION SUMMARY
This
role is
Ensuring
& Supporting Quality process during development of the product as per the
guidelines of various regulatory authorities.
|
3,
OVERALL JOB RESPONSIBILITIES
|
Responsibility
|
Results Expected/
Target
|
% of time spent
|
1
|
Financial Health
|
·
Manage departmental budget to
ensure planning and spending is within approved budgets and consistent with
established corporate operating expense goals and in line with corporate
processes.
·
Ensure to support the development process on time
& within budget
·
Manage internal resources and external relationships
as required to ensure 90% timely delivery of data
|
|
2
|
Drive sustainable
growth
|
·
Ensure timely delivery of the product without any non
compliance issue with the regulatory authorities.
·
Ensure that the facility is functioning as per the
set procedure and in a compliant manner and that there are no deviations from
the set procedure & regulatory requirements.
·
To implement internal audits as well as regular
surveillance audits in all R&D departments
·
Support and guide preparation of responses to
regulatory agency
·
Function as and when required as an expert liaison
between company and external stakeholders
|
|
3
|
Build process
excellence to manage growing complexity of operations
|
·
To ensure Product development as
per quality requirements of various regulatory authorities.
·
Build strong SOPs to ensure a Quality
approach to work
·
Ensure the coordination between
formulation & Analytical formulation, API Process research &
Analytical API, PKD & Clinical Research on quality aspects
·
To ensure internal Consistency and compliance & regulatory requirements.
·
To ensure effective implantation of CAPA
resulting in continual improvement
|
|
4
|
Build
organizational capability
|
·
Build a strong team with scientific
capability to ensure the quality systems across various stages in the R&D
·
Training and auditing Lab teams on Quality
techniques to ensure best in class approaches to conclusions &
assessments
·
Hire and retain best in class talent
within the function with a view to build long term org capability across key
therapies
·
Partnering with HR in
developing and building scientific capabilities in the organization.
·
Responsible for driving
career advancement plans, objective / goal setting, deciding on the KRAs for
direct reports (DRs) and ensuring a similar approach for down the line
reporting in the organization.
|
|
4,
KEY INTERFACES / INTERACTIONS
External Interfaces
|
Internal Interfaces
( Other than Direct Reports)
|
Any external interested party for auditing
system, FDA, External outsourcing laboratories, any individuals from other
location for the documents requirement.
|
All HODs, Group Leaders, scientists
|
6,
KNOWLEDGE, SKILLS AND ABILITIES
Indicate the education
level, previous experience, specific knowledge, skills and abilities required
to meet minimum requirements for this position.
Education
(degree
/ diploma)
|
MPharm
/PhD
|
Experience
|
15-20 yrs
|
Knowledge and Skills
(Functional
/ Technical)
|
Strong understanding of the Quality Assurance/Clinical
Research/Bioanalytical
processes. Knowledge in Quality management for API as well formulation
w.r.t. GMP, GLP requirement as laid by USFDA, EU, WHO etc. Working experience
from
ADL,
QC, QA.
|
Leadership /
Managerial Attributes
|
Should have experience to lead the team
of 10 to 15 people, Good communication & presentation skills,
|
Other requirements (licenses,
certifications, specialized training)
|
|
Salary 60 lacs but not a constraint for a suitable candidate.
Should you be interested, kindly forward your Cv at alpana@alevelplacements.com asap.