3+ QMS Jobs in India

Have you ever dreamed of being part of new product initiatives? Feel the energy and excitement to work on version 1 of a product and bring the "Idea on Paper" to life. Do you crave to work on SAAS products that can become the next Uber, Airbnb, or Flipkart? We give you the opportunity to be part of a team that will be leading the development of a SAAS product.

Our organization relies on its central engineering workforce to develop and maintain a product portfolio of several different startups. Our product portfolio continuously grows as we incubate more startups, which means that various products will likely use other technologies, architecture, & frameworks - a fun place for smart tech lovers!

We are looking for a Principal Product Manager (Quality, Life Sciences) to join our engineering teams at our offices in Hyderabad (Hybrid Mode).

What will you be working on?

CAW is building a next-generation QMS for small and medium life sciences companies. The product will have a modern UI and be fast and sleek, everything the current bunch of QMSs lacks. It will consist of Quality Elements such as Controlled, User Record, Change Control,  CAPA, Events,  Partner, and Risk Management - considered as “Category V” of GAMP5.

You will be a combination of senior product manager for the product. You will be -

• Liaising with the client for requirements gathering. Your experience in life sciences will help you understand the requirements faster than anyone. 
• Your experience with working with similar products will help shape the product roadmap. You will not just be gathering requirements but even defining the roadmap.
• You will help convert these requirements to acceptance criteria and PRD.
• You will work with the design team to create user-friendly interfaces based on product UI Standards.
• You will work with the engineering team for requirement walk-throughs and clarifications.
• You will be reviewing test cases to ensure they confer the requirements
• You will help test the product to validate its functionality.
• You will be pulled into end-customer meetings for product demos. You will also be leading new customer onboarding.

Who should apply?

• 8+ years of related experience or equivalent combination of education/training and experience. 5+ years of management responsibilities in life sciences organizations.
• Expert in QMS processes, including Controlled Document Management, Learning Management (Training), Deviation/Event Investigation, Corrective and Preventive Action (CAPA), Product Complaints, Change Control Management, and Audits and Inspections.
• Provides quality systems services to clients, including vendor qualification, Computerized System Validation (CSV) oversight, and project management.
• Coordinates with clients and vendors to determine the best fit for QMS technology solutions.  Defines QMS processes based on industry best practices and documents requirements for computerized system selection and development.
• Plans and implements software development and/or IT hosting vendor qualification via questionnaire, documentation review, and Auditing.
• Supports the development of client and QMS policies, procedures, and work instructions for administering and using computerized systems. Provides SME input and training for QMS processes and computerized system use.
• Assists with implementing and managing client and QMS processes and computerized system business administration (e.g., document control, training coordination, incident/change management).
• Assists clients with audit/inspection readiness, including standard operation procedure (SOP) preparation, mock audits/inspections, and “back room” coordination. Supports and participates in QMS audit/inspection responses and CAPA development.
• Identifies areas within client Quality and IT departments where can provide assistance and support. Communicates and coordinates between Client and Celito to define needs and manage engagements.
• Contributes to QMS software development, including process definition/design, system review, and development testing for functionality and User Interface (UI), as well as validation, training, and system support documentation.

About CAW Studios

We are a Product Engineering Company of 150+ geeks.

We run engineering for startups like Hoichoi.tv, Interakt, CashFlo, hBits, FastTI, Fhynix, BeTagged, FastBar, Haptik, CloudDefense, AccelData Flipspaces, Aerchain, and Reeco. 

We are obsessed with automation, DevOps, OOPS, and SOLID. We are not into one tech stack - we are into solving problems.

Find us: https://goo.gl/maps/dvR6L26JUa42

Website: https://www.cawstudios.com/

Know More: https://www.cawstudios.com/handbook

At Prolifics, we are currently implementing multiple solutions on PCQA Manager for our development centre in India. This position would be based out of Hyderabad location and is a permanent position.

If you are looking for a high growth company with rock-solid stability, if you thrive in the energetic atmosphere of high profile projects, we want to talk to you today! Let’s connect and explore possibilities of having you onboard the Prolifics team!

Job Title:                    Manager - PCQA

Primary skills:                7+ years of experience

Location:                    Hyderabad

Educational Qualification:      B.Tech/BE/M.Tech/MCA/M.Sc

JD:

 The PCQA Manager is a key role to support the process improvement (CMMI V2.0) initiative that will help assess the quality of the software delivered by a growing Software Development Company to its customers. This role will be part of the PCQA team, which helps the organization sustain SEI CMMI DEV Level 5, upgrade to CMMI V2.0 and support other methodology related initiatives.

• Lead the PCQA team and be flexible to take up assignments within the team such as Coaching, Auditing, implementation, process improvement projects, QMS process improvements, agile practices implementation etc.
• Mentor the team in the development and implementation of QMS aligning to CMMI V2.0 within the organization across geographies
• Identify improvements opportunities in the existing policies, processes, procedures, templates and metrics for the organization
• Define and utilize metrics and reports to manage quality efforts
• Prepare and conduct quality assurance product reviews and prepare projects teams ready for process audits according to the audit plan
• Sound understanding of Process Frameworks/Methodologies like CMMI-Dev, SVC, AGILE SCRUM etc.
• Good understanding of various software development life cycles
• Ability to influence and drive delivery with global senior management
• Attention to detail while keeping a global perspective, willing to deep-dive for data analysis
• Good communication and interpersonal skills to interact with global stakeholders
• Very good understanding of Information security concepts and implementation experience of ISO 27001 and other security standards is a value add

About us:

Prolifics Corporation Limited is a Global Technology Solutions Provider with presence across North America (USA and Canada), Europe (UK and Germany), Middle East & Asia. In India, we have off shore development centers: 3 in Hyderabad & 1 in Pune.

For more than 40 years, Prolifics has transformed enterprises of all sizes including over 100 Fortune 1000 companies by solving their complex IT challenges. Our clients include Fortune 50 and Fortune 100 companies across a broad range of industries including Financial Services, Insurance, Government, Healthcare, Telecommunications, Manufacturing and Retail. We rank consistently in Dream Companies to Work For and Dream Employer of the Year ranking from World HRD Congress, ranked 7 in 2019.

We encourage you to visit us on www.prolifics.com or follow us on Twitter, LinkedIn, Facebook, Youtube and other social media to know more about us.

• Working closely with the external auditors to achieve common goals
• Conducting Enabling Service Audit (HR, Admin, IT) once in 6 months for the verification of ISMS & QMS Standards
• Performing ISMS and Internal Audit
• Being part of the external Audits (ISMS, QMS & CMMI)
• Managing of implementation of ISMS

Desired Candidate Profile

• Strong communication and team building skills with proficiency at grasping new technical concepts quickly and utilizing the same in a productive manner
• Experience in ISO27001, Internal Audits, CMMI