2 Ich Regulations Jobs

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.