Product Quality Specialist
1 week ago
This role will support one or more late-stage and/or commercial biologics or synthetics products. The individual will provide project support to the relevant Product Quality Team (PQT) to implement and manage strategy for Quality to meet the Product Quality goals. The individual will be directly responsible for Product Quality related tasks including authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (document management system, complaint resolution system, data systems), and product data management, including stability, comparability assessments, periodic and annual product reviews (APR). In addition, the candidate will be expected to play a role in supporting Product Quality initiatives intended to ensure the overall product health.
- Support PQ work for late-stage and/or commercial biologic or synthetic programs, including actions required for the PQT, APR, specifications, comparability, stability programs, and PQ owned regulatory filing sections and responses to questions (RTQ)
- Support science and risk-based evaluation of complex process and product quality data such as in-process, release and stability data, complaints, method performance etc.
*What we expect of you*
Basic Qualifications and Experience:
- Doctorate degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 2 years of Quality, Operations, Scientific, or Manufacturing experience, or
- Masters degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 6 years of Quality, Operations, Scientific, or Manufacturing experience, or
- Bachelors degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field & 8 years of Quality, Operations, Scientific, or Manufacturing experience or
*Preferred Qualifications:*
Must-Have Skills:
- Demonstrate proficiency in oral and written communication of complex information to Product Quality team members and peers
- Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
- Strong scientific data management and organization skills with attention to detail
- Ability to deliver high quality results and adhere to project timelines using computer-based GMP Quality systems
- Ability to build and maintain multi-functional relationships and strong partnerships through written and verbal communication skills
Good-to-Have Skills:
- Experience working virtually on a multi-functional team in a matrix environment across multiple time zones
- Expertise in computer applications such as Veeva, Spotfire, SHINY
- Expertise in MS Office (Word, Excel, PowerPoint, MS Teams)
Soft Skills:
- Analytical and problem-solving skills
- Ability to work effectively with global, virtual teams
- High degree of initiative and self-motivation
- Ability to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelines
- Team-oriented, with a focus on achieving team goals
- Strong presentation and public speaking skills
-
Product Development Specialist
3 days ago
Hyderabad, Telangana, India Unified Excellence Full time ₹ 5,00,000 - ₹ 15,00,000 per yearWe are hiring a Food Innovation Specialist to develop new, high-quality food products for our in-house brand.The role includes concept creation, recipe trials, cost optimization, quality testing, and collaboration with chefs, R&D, and marketing team. Required Candidate profileFood tech graduate with 2–5 yrs in R&D or product dev. Skilled in trials,...
-
Product Specialist
1 day ago
Hyderabad, Telangana, India Assentcode Technologies Full time ₹ 5,00,000 - ₹ 8,50,000 per yearJob Description – Product Specialist (EdTech | Fresher to 1 Year Experience | Hyderabad – Immediate Joiners Preferred)Location:Hyderabad, IndiaEmployment Type:Full-Time | On-Site with Frequent TravelAbout the CompanyAssentcode Technologies is a rapidly growing IT services and product engineering organization that thrives on innovation, client success,...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 10,00,000 - ₹ 25,00,000 per yearWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 10,00,000 - ₹ 25,00,000 per yearWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Supplier Quality Specialist
2 weeks ago
Hyderabad, Telangana, India Net2Source (N2S) Full time ₹ 6,00,000 - ₹ 12,00,000 per yearPosition: Supplier Quality SpecialistLocation: Hyderabad, TGNet2Source, in collaboration with one of ourpremium clients, is seeking aSupplier Quality Specialistto join their team inHyderabad. If you have a background in engineering and strong expertise in supplier quality, this is a great opportunity to grow in a global environment.Qualification &...
-
Quality Specialist
2 days ago
Hyderabad, Telangana, India Amazon Full time US$ 80,000 - US$ 1,20,000 per yearThe Last Mile Analytics & Quality Team is looking for Transportation Quality Specialist who will act as first level support for Last Mile team with multiple transportation services along with other operational issues and activities related to transportation process and optimization.Your solutions will impact our customers directly This job requires you to...
-
Product Owner/Consultant Specialist
7 days ago
Hyderabad, Telangana, India HSBC Full time ₹ 12,00,000 - ₹ 36,00,000 per yearSome careers shine brighter than others.If you're looking for a career that will help you stand out, join HSBC and fulfil your potential. Whether you want a career that could take you to the top, or simply take you in an exciting new direction, HSBC offers opportunities, support and rewards that will take you further.HSBC is one of the largest banking and...
-
Quality Specialist
2 days ago
Hyderabad, Telangana, India Amazon Full time ₹ 8,00,000 - ₹ 10,00,000 per yearDESCRIPTIONThe Last Mile Analytics & Quality Team is looking for Transportation Quality Specialist who will act as first level support for Last Mile team with multiple transportation services along with other operational issues and activities related to transportation process and optimization.Your solutions will impact our customers directly This job...
-
Quality Specialist
1 week ago
Hyderabad, Telangana, India Amazon Full time ₹ 5,00,000 - ₹ 15,00,000 per yearThe Last Mile Analytics & Quality Team is looking for Transportation Quality Specialist who will act as first level support for Last Mile team with multiple transportation services along with other operational issues and activities related to transportation process and optimization.Your solutions will impact our customers directly This job requires you to...
-
Quality Specialist
2 weeks ago
Hyderabad, Telangana, India Amazon Full time ₹ 4,00,000 - ₹ 12,00,000 per yearThe Last Mile Analytics & Quality Team is looking for Transportation Quality Specialist who will act as first level support for Last Mile team with multiple transportation services along with other operational issues and activities related to transportation process and optimization.Your solutions will impact our customers directly This job requires you to...
