Sr Professional Quality Managament

Syneos Health, Inc.; Pune District; On-site; INR 1,400,000 - 2,200,000; Full time

Job summary

Syneos Health is seeking a Quality Assurance professional to support GXP activities across Clinical departments. The role involves audits, training documentation reviews, RCA/CAPA work, and quality consultancy to ensure compliance with regulatory standards.

Responsibilities include supporting sponsor site audits, preparing audit materials, and advising on procedural documentation while travelling up to 15% of the time.

Qualifications

• BA/BS in science or health care related field; GCP/GXP knowledge preferred.
• Proficiency with MS Office; strong documentation skills.

Responsibilities

• Supports Clinical Monitoring (CM) teams through sponsor site audits.
• Assist CM teams during site audits by performing quality checks on training documentation/TMF/study documents.
• Assist CM teams during Audits and Inspections to determine underlying issues, perform RCA, formulate CAPAs, and implement Effectiveness Checks.
• Provides quality support and consultancy for Quality Management and Operations, as applicable.
• Works within a specific knowledge area; may work outside area.
• Ensures commitments and timelines for assigned activities adhere to Syneos Health requirements.
• Offers solutions to process and quality related issues and identifies process improvement opportunities.
• Advises QA auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
• Reviews controlled documents, providing input on content alignment with standards and technical content.
• Solves moderately complex problems and/or conducts analyses; translates concepts into practice.
• Makes decisions that impact a range of standard and non-standard operational, process, project or service activities.
• Represents Quality Management as assigned.
• Travels may be required (approximately 15%).

Skills

GCP/GXP expertise

Audits & inspections

Quality management

MS Office

Analytical thinking

Education

BA/BS in science or health care

Tools

MS Office

Job description

Updated: Today
Location: Yerawada, MH, India
Job ID:25112415-OTHLOC-5448-2DH

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Job Summary

Performs various activities (analysis, investigation, reporting, administration) related to ‘GXP’ (e.g. Good Clinical Practice or Good Pharmacovigilance Practice) and related topics for Clinical departments (therapeutic areas and functions).

Core Responsibilities

• Supports Clinical Monitoring (CM) teams through the duration of sponsor site audits
• Work with CM teams for the preparation of site audits, which includes performing quality checks on training documentation/TMF/study documents.
• Assist and work with CM teams during Audits and Inspections to determine underlying Issues, perform Root Cause Analysis (RCA), formulate appropriate Corrective and Preventative Actions (CAPAs), and implementing Effectiveness Checks.
• Provides quality support and consultancy for Quality Management and Operations, as applicable
• Works within a specific knowledge area. May work outside area.
• Ensures commitments and timelines for assigned activities adhere to Syneos Health requirements.
• Offers solutions to process and quality related issues and identifies process improvement opportunities
• Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
• Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
• Solves moderately complex problems and/or conducts analyses. Translates concepts into practice.
• Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
• Serves as a key resource within a business area or discipline.
• Anticipates and resolves problems, which may be moderately complex. Applies critical thinking to identify solutions to requests and problems
• Drives solutions for products, processes, and services
• Leads medium-scale Quality Management projects or programs with moderate risks and resource
• Normally receives little instruction on day-to-day work, general instructions on new assignments
• Represents Quality Management, as assigned
• Performs other quality-related activities as directed by management
• This position is not responsible for supervising employees
• Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
• Travel may be required (approximately 15%)

Qualifications

Education Requirements

Min/Preferred Education Level Description

• BA/BS degree in science or health care or equivalent education and experience, plus some experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) preferred.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.
• Above average attention to detail and accuracy.
• Strong organizational, interpersonal and team-oriented skills.
• Ability to act independently and pro-actively.
• Significant project management and customer management skills.
• Ability to perform several tasks simultaneously to meet deadlines.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our more than 29,000 employees already know: work here matters everywhere. We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Selecting us as an employer secures a career inwhich you’re guaranteed to:

Syneos Health ® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.