Jodas is a Global, specialty, innovation driven, emerging, generic bio- pharmaceutical company, that is asserting itself among the worlds foremost pharmaceutical companies. JEPL is having EU GMP certification of Oncology (orals), Contrast Media (SVP and LVP) and facility for Cephalosporins currently delivering the products like Anti-Cancer and Antibiotics.
LOOKING FOR EU/ROW Market, FR&D – JD, Injectables QA Validation Specialist
FR&D – JD (Injectable)
Designation : RA I/ RA II
Experience : 3-8 years
Qualification : B. Pharma/ M. Pharma
Number of Persons Required : 05 (Injectable)
Location : Karakapatla, Hyderabad
Job Description
• Review of Literature and patents and preparation of Pre-product development strategy.
• Execution of experimental work and reporting of observations.
• Compilation of pre-formulation data on the drugs and excipients used in the formulations.
• Preparation of tentative and final input specifications.
• Preparation of master formula records, process characterization protocols and reports and Product development reports and other related documents for dossier filing.
• Execution of process evaluation, optimization, scale-up and exhibit batches for new products and products being amended.
Injectables QA Validation Specialist
Designation : Executive/Sr Executive/Assistant Manager
Experience : 3-10 years
Qualification : B Pharm/M. Pharm
No of Positions : 05
Job Summary : We are looking for an experienced Injectables QA Validation Specialist to ensure the quality and compliance of injectable drug products during the validation process. The role involves managing QA activities for injectables, ensuring adherence to industry standards and regulatory requirements.
Key Responsibilities :
• Plan, execute, and document validation activities for injectable drug products.
• Oversee qualification of equipment, facilities, and systems used in production and testing.
• Develop and review validation protocols (IQ, OQ, PQ).
• Ensure all validation activities comply with GMP, FDA, EMA, and other regulations.
• Identify risks and implement corrective actions.
• Collaborate with cross-functional teams to resolve quality issues.
Qualifications :
• B.Pharm / M.Pharm
• 3-8 years in QA-Validation
• Strong knowledge of GMP, FDA, EMA, and ICH standards
• Experience with process validation and equipment qualification
• Excellent attention to detail, communication, and problem-solving skills
EU/ROW Market – JD (Parenteral Dosage Formulations)
Designation : Executive/Sr Executive
Qualification : B Pharm/M. Pharm
No of Positions : 05
Experience : 2 –7 years preferably with sufficient hands on experience in Europe/ROW Regulatory Affairs.
Job Description : This position is responsible for preparing EU/ROW Parenteral dossiers and guiding the technical review and finalization of documents for regulatory filings. The role ensures high-quality, timely documentation to meet organizational goals and secure faster approvals with minimal queries. It also maintains regulatory compliance throughout the product life cycle.
Key Accountabilities
• Review and prepare EU/ROW filing documents (Modules 2 & 3) for Parenteral Dosage Forms.
• Understand and apply EU/ROW Regulatory Guidance and ICH/EMEA guidelines.
• Knowledge of Parenteral Dosage Formulation and analytical aspects.
• Manage post-approval variations and assess the impact of change controls.
• Demonstrate strong time-management skills and adaptability to changing priorities.
• Maintain a positive attitude and guide cross-functional teams.
Basic Skills
• Strong written and verbal communication.
• Proficiency in MS Office, Excel, and basic software tools.
Location : Plot No S-1, Sy No: 1043 & 1048, 3rd Floor, NSL Centrum, KPHB Phase 3, Kukatpally, Hyderabad, Telangana - 500072
Interested candidates can share their updated resume to : recruitment3@jodasexpoim.in
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