CQV Manager

Integrated Project Services International

10 - 15 years

3 - 7 Lacs

mumbai

Posted:1 day ago| Platform:

Apply

Skills Required

document review staffing project management analytical pharma master planning gap analysis gmp ips team building

Work Mode

Work from Office

Job Type

Full Time

Job Description

Directly responsible for the successful delivery of compliance projects to IPS clients Works with IPS CQV/Project management team to develop and apply quality practices for all project deliverables and business practices
In conjunction with the Project management team, performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients
Promote efficiency in staff utilization
Manages and assigns regional resources to meet project requirements
Works with other Regional Managers and other IPS disciplines to maintain targeted / budgeted utilization
Tracks staff assignments, makes resource projections, and makes necessary adjustments as required
Prepares workload forecasts to support staffing management
Leads, mentors, trains, and manage team of compliance staff assigned to the respective regional office
Assists and mentors staff to set performance and career goals
Provides routine feedback and conducts formal time-based performance reviews
Implement corrective action plans as required
Generates and performs C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals
Works with potential new and existing clients to initiate projects following current industry practices
Performs strategic and master planning activities to assure projects are initiated/started on the right foot
Preparation of project monthly report, Management of various GEP and GMP documents, QMS Document review and Gap analysis Ensures the quality, accuracy, and completeness of overall work as to CQV Department, compliance with established IPS and client standards, procedures, codes, and ordinances
Guidance for implementation of Biotech/Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications / datasheets, and user requirement specifications Track Quality deliverables by strong interaction with inhouse team, clients & vendors Directly responsible for the successful delivery of compliance projects to IPS clients Works with IPS CQV/Project management team to develop and apply quality practices for all project deliverables and business practices
In conjunction with the Project management team, performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients
Promote efficiency in staff utilization
Manages and assigns regional resources to meet project requirements
Works with other Regional Managers and other IPS disciplines to maintain targeted / budgeted utilization
Tracks staff assignments, makes resource projections, and makes necessary adjustments as required
Prepares workload forecasts to support staffing management
Leads, mentors, trains, and manage team of compliance staff assigned to the respective regional office
Assists and mentors staff to set performance and career goals
Provides routine feedback and conducts formal time-based performance reviews
Implement corrective action plans as required
Generates and performs C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals
Works with potential new and existing clients to initiate projects following current industry practices
Performs strategic and master planning activities to assure projects are initiated/started on the right foot
Preparation of project monthly report, Management of various GEP and GMP documents, QMS Document review and Gap analysis Ensures the quality, accuracy, and completeness of overall work as to CQV Department, compliance with established IPS and client standards, procedures, codes, and ordinances
Guidance for implementation of Biotech/Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications / datasheets, and user requirement specifications Track Quality deliverables by strong interaction with inhouse team, clients & vendors Must be able to demonstrate competency in performing the responsibilities of a CQV Manager Bachelor s degree in engineering or a related field preferred A minimum of 10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software
Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes
Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design / Build / Commission / Validate processes and how they relate to regulatory requirements and cGMP regulations Progressive ability, capacity, and aptitude in administration to plan, organize, supervise, and coordinate technical work and to obtain cooperation from others
Analytical thinking, structured problem-solving skills, superior communications skills, team building and strong work ethics
Must be able to build rapport with department staff Job Description Directly responsible for the successful delivery of compliance projects to IPS clients Works with IPS CQV/Project management team to develop and apply quality practices for all project deliverables and business practices
In conjunction with the Project management team, performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients
Promote efficiency in staff utilization
Manages and assigns regional resources to meet project requirements
Works with other Regional Managers and other IPS disciplines to maintain targeted / budgeted utilization
Tracks staff assignments, makes resource projections, and makes necessary adjustments as required
Prepares workload forecasts to support staffing management
Leads, mentors, trains, and manage team of compliance staff assigned to the respective regional office
Assists and mentors staff to set performance and career goals
Provides routine feedback and conducts formal time-based performance reviews
Implement corrective action plans as required
Generates and performs C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals
Works with potential new and existing clients to initiate projects following current industry practices
Performs strategic and master planning activities to assure projects are initiated/started on the right foot
Preparation of project monthly report, Management of various GEP and GMP documents, QMS Document review and Gap analysis Ensures the quality, accuracy, and completeness of overall work as to CQV Department, compliance with established IPS and client standards, procedures, codes, and ordinances
Guidance for implementation of Biotech/Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications / datasheets, and user requirement specifications Track Quality deliverables by strong interaction with inhouse team, clients & vendors Qualifications & Requirements Must be able to demonstrate competency in performing the responsibilities of a CQV Manager Bachelor s degree in engineering or a related field preferred A minimum of 10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software
Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes
Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design / Build / Commission / Validate processes and how they relate to regulatory requirements and cGMP regulations Progressive ability, capacity, and aptitude in administration to plan, organize, supervise, and coordinate technical work and to obtain cooperation from others
Analytical thinking, structured problem-solving skills, superior communications skills, team building and strong work ethics
Must be able to build rapport with department staff

More Jobs at Integrated Project Services International

Jr. TA Executive

Mumbai

Experience: Not specified

Salary: Not disclosed

CAD Designer ( Architecture)

Mumbai

3.0 - 7.0 yrs

INR 5 - 9 Lacs

Electrical Designer

Mumbai

2.0 - 6.0 yrs

INR 1 - 4 Lacs

Instrumentation Engineer

Mumbai

15.0 - 20.0 yrs

INR 3 - 7 Lacs

Piping Designer

Mumbai

5.0 - 10.0 yrs

INR 7 - 12 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.