Manager CQV
Manager CQV
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Job Description
Location: Bangalore India
Seniority: 15 yrs.
Department: Commissioning and Qualification (USP / DSP / Clean utilities)
How you might spend your days (Main Roles & Responsibilities)
As Manager – C&Q you’ll be working with highly skilled Senior Engineers and Engineers and still growing across
Denmark and Indian team’s where you’ll:
Would be part of the Project team involved in making complex biopharma/Large API facilities
Driving the project with Science and Risk based Validation (SRV) concept.
Work very closely with our customers Extensive Travelling Involved.
Have strong leadership qualities to lead a team of C&Q Engineers/Leads and aligning with Multiple
stakeholders.
Have knowledge of process equipment’s systems
To drive C&Q activities with multiple stakeholders like (Engineering responsible Design consultant
Vendor’s and QA) of the project organization:
Align quality and validation concept with customer’s quality system & validation concept
Define scope of C&Q activities in project and scope of work within quality work package incl. relevant
C&Q activities
Ensure changes to scope are brought to the attention of Project Management.
Ensure interfaces to and coordination with other disciplines
Review work of project members in the quality work package.
Generate validation deliverables like IQ OQ PQ protocols and reports etc.
Act as Smarter Execution consultant for Project Members.
Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
Conduct follow-up on QAP Project execution Plan on C&Q activities
Having work experience on QMS based Project environment
Who you are (Preferred Competencies)
We care about who you are as a the end how you work and your energy is what impacts the effort we do
as a team. As a Biotech person you:
Project management skills regarding C&Q facilitating board meetings to review status
timelines quality challenges generating reports for steering group understanding to
evaluate risk and its mitigation strategies.
Thrives in a fast-paced environment with many concurrent tasks.
Need to train the team in performing the site activities and handling different stakeholders.
Support onsite and offsite activities such as: FATs SATs IOQ and PQ Executions and System
Walkdowns.
Hands on experience in planning / directing C&Q activities of process equipment’s (upstream
and downstream and clean utilities) in DS facility qualification
Should have experience in validation deliverables like URS design review P&IDs FAT SAT IQ OQ
PQs Test protocols and reports generation & execution etc.
Should have good communication and collaboration skills enabling interaction with many
stakeholders from different functions and cultures.
The miles you’ve walked (Education and Work Experience)
In all positions there are some things that are needed and others a bonus. We believe these qualifications are needed
for you to do well in this role:
Bachelor’s or master’s degree in a relevant science engineering or pharmaceutical field.
15 years experience performing commissioning and / or qualification activities in an FDA regulated
industry.
Ideally you will already have experience in equipment qualification.
Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines
USFDA EU GMP Annexure 11 & 21 CFR 11 and ICH guidelines.
Employment Type
Full Time
