18 fda jobs in Gurugram, India.

... - mandatory - Proficient in Microsoft Office - English level - advanced 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 ...

... skills with the ability to express ideas and collaborate effectively with multi-disciplinary teams. - Excellent analytical and problem-solving skills including risk management experience. Preferred Qualification: - PMP or equivalent preferred - Has applied knowledge of FDA & International medical device regulations ere.

... Detail oriented with a high degree of accuracy and ability 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 ...

... documentation, including protocols, reports, and standard operating procedures (SOPs). - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM). - Coordinate with cross-functional teams to ensure seamless project execution. - Provide regular project updates ...

... experience in drafting and reviewing narratives. • Should be a Postgraduate (Masters /Mpharm ) or bachelor’s degree. • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. • Demonstrated high degree of independence with effective presentation, proofreading, ...

... execution of validation plans, URSs/DQ/TMs/FATs/SATs/IQ/OQ protocols/reports. - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM) and meets data integrity (ALOCOA+) principles. Well versed in commissioning and qualifying CIP & SIP systems Here's ...

... of the key certifications include: - ISO 13485:2016 (Quality Management Systems for Medical Devices) - ISO 14971:2019 (Risk Management for Medical Devices) - FDA Compliance (21 CFR Part 820) : Hollister complies with FDA regulations for medical device manufacturing. - CE Marking : For products sold in the European Union, ...

... to our talent pipeline and considered should this role become available. 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 ...

... roles - Experience in payment processing or financial operations is a plus 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 ...

... - mandatory - Proficient in Microsoft Office - English level - advanced 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 ...

... work-related duties as assigned. - Minimal travel may be required (less than 25%). 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 ...

... Acts in an Ethical and Compliant manner and requires other to do the same 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 ...

... level for at least one Project. Technical Skills: - Experience with paperless validation software such as KNEAT and/ or Valgenesis. - In-depth knowledge of cGMP, FDA, EMA, and other relevant regulatory requirements. - Strong project management skills with the ability to handle multiple priorities across national and international ...

... to our talent pipeline and considered should this role become available. 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 ...

... project to project. - Fluent in speaking, writing, and reading English. 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 ...

... level in the work environment is low. This is a largely sedentary role. 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 ...

... priorities while delivering high quality work in a dynamic environment. 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 ...

... to our talent pipeline and considered should this role become available. 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 ...