234 Sterile Jobs - Page 10

Dear Candidate, We are looking for formulation scientists for our Ophthalmic and Nasal teams in Formulations, focusing on the formulation development of sterile ophthalmic dosage forms solutions, suspensions, and emulsions. This role involves complete ownership of formulation and process development with a strong emphasis on regulatory compliance and timely execution. Position1: Assistant Manager Department: Ophthalmic team - Formulation Development Required Exp : 8-12years Position2: Research Associate/Sr.Research Associate Department: Nasal team - Formulation Development Required Exp: 4-8years(Candidates from injectables background can also apply.) Role & Responsibilities: Formulation & Process Development Independently develop formulations for ophthalmic, injectables and nasal sprays Design and interpret DoE studies for optimization and robustness Technology & Excipient Evaluation Select excipients, containers/closures, and delivery systems (BFS, vials, spray pumps) Conduct risk assessments for compatibility, leachables, and functionality QbD & Risk Mitigation Define QTPP, CQA, and CPPs Apply DoE-based approaches for robust formulation and process design Scale-up & Technology Transfer Design scalable processes and identify critical material and process attributes Support scale-up, exhibit, and validation batches (in-house/CMO) Regulatory Documentation Prepare 3.2.P.2 / 3.2.P.3 sections, development reports, and risk assessments Address regulatory queries and support ANDA / 505(b)(2) filings DeviceDrug Integration Oversee device evaluations (spray pattern, plume, PSD, E&L) Ensure alignment between formulation and device requirements Cross-functional Collaboration Work closely with ARD, QA, RA, SCM, device, and manufacturing teams Coordinate packaging/device-related studies and tech transfer activities Project & Team Management Lead development of complex sterile products Mentor junior team members and ensure GLP/documentation compliance Drive timelines in alignment with CMC and regulatory milestones Required Skills and Qualifications: M.Pharm (Pharmaceutics) Strong understanding of formulation science, aseptic processing, and regulatory pathways (USFDA and other markets) Hands-on experience with E&L studies, ICH Q3D, and risk-based development Proven problem-solving skills and scale-up troubleshooting Experience with CMO/CRO coordination and technology transfer Benefits: 5day week, Canteen/Bus facility, Mediclaim, accidental benefits..etc. Suitable and Interested candidates can share their profiles along with basic details curr.org., total exp, Curr.Location, CTC,Expected CTC, Notice period..etc Mail ID: kiran.k@orbicular.co.in / pranathi.p@orbicular.co.in Ph.No 9000251866 Regards Team HR.

Supervise daily production activities of injectable formulations. Ensure compliance with cGMP, safety, and quality standards. Plan and execute production schedules to meet targets Coordinate with QA, QC, Maintenance, and Warehouse teams. Required Candidate profile Lead and train production staff for operational efficiency. Handle documentation: BMRs, SOPs, deviations, and change controls. Support audits – internal, regulatory (USFDA, EU, WHO-GMP).

Hi, We have urgent position open for the Warehouse Executive / Junior Executive role. Responsible for managing the receipt, storage, issuance, and documentation of materials (raw, packaging, and finished goods) in compliance with cGMP, GDP, and company SOPs. Ensures material traceability, cleanliness, and timely supply to production particularly for sterile/injectable operations. Key Responsibilities: 1. Material Handling & Storage 2. Documentation & Compliance 3. Material Issuance 4. Cleanliness & Safety 5. Vendor Coordination & Dispatch (Optional)

Role & responsibilities Working as a Production Chemist. Experience into BMR, BPR. Experience in Sterile, sterilization. Batch Planning, Batch Manufacturing

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assurance. Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the Lan and insure implementation within the department. Maintain thorough knowledge and understanding of regulatory requirements pertaining to microbiology and sterility assurance testing. Play a lead role in the review and approval for appropriate department SOPs, protocols, and data forms. Ensure equipment maintenance and calibration performed within the department meets the calibration/maintenance schedule. Take a lead role in validating new equipment or testing procedures. Regularly attend meetings and seminars to stay current with industry practice. . Required Skills Have good communication skills. Logical Thinking Organizing Required Qualification: - M.sc -Microbiology

Cleaning, disinfecting, sterilizing, and distributing surgical instruments and medical equipment. Ensures proper functioning of sterilization processes, maintains hygiene standards, and follows infection control protocols.

Job Role: Junior Associate to Senior Associates Manufacturing (Injectables) Eligibility criteria: Qualification: Any Diploma/BSc/B.Pharma/MSc/M.Pharma Years of Experience: 2 to 10 Years should be from injectable manufacturing plant. Job Description Operate production equipment such as Injectable , Sterile , Parenteral machines, Vial / Ampoule filling , Capping , Compounding , Washing ,Sealing, Terminal sterilization, Stopper process & Visual inspection. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance tasks on equipment as required. Collaborate with other team members to resolve issues and improve overall efficiency. Ensure adherence to Good Manufacturing Practices (GMP) guidelines. Must have experience with USFDA regulatory environment & process.

*Job Description:* We are seeking a highly motivated and detail-oriented Production Executive specializing in Dry Injection to join our dynamic team. The successful candidate will be responsible for overseeing the manufacturing processes of dry injection products, ensuring compliance with industry regulations, and maintaining high standards of production quality. *Key Responsibilities:* - Oversee daily production activities related to dry injection products and ensure smooth operations in the manufacturing unit. - Ensure adherence to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). - Monitor production schedules and adjust as needed to meet targets and deadlines. - Collaborate with quality assurance and regulatory teams to ensure compliance with industry standards. - Identify areas for process improvement and implement changes to enhance efficiency and productivity. - Manage and train production staff, ensuring they are well-informed and equipped to perform their duties. - Maintain accurate records of production activities, inventory, and equipment maintenance. - Troubleshoot and resolve any production-related issues promptly. - Ensure safety protocols are followed to maintain a safe working environment. - Assist in the preparation of production reports and performance metrics. *Qualifications:* - Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related field. - Minimum of [X] years of experience in a production role within the pharmaceutical industry, specifically in dry injection manufacturing. - Strong knowledge of GMP, SOPs, and regulatory requirements. - Excellent problem-solving and decision-making skills. - Ability to work effectively in a team environment and manage multiple tasks. - Strong communication and interpersonal skills. - Proficiency in using production management software and tools. *Benefits:* - Competitive salary and performance-based bonuses. - Comprehensive health, dental, and vision insurance. - Retirement savings plan with company match. - Opportunities for professional development and career advancement. - A supportive and collaborative work environment. *How to Apply:* Interested candidates are invited to submit their resume and cover letter to [marclabs113@gmail.com,aks_marc@yahoo.com] and WhatsApp No 6230915320 interested candidate can appear for walk in along wiht updated CV, ID proof, Passport size photograph and salary proof Mobile No: 9805238996/7018914894/6230915320 with the subject line "Production Executive -Dry Injection Applications will be reviewed on a rolling basis until the position is filled.

Qualification: Post-graduate in Pharmacy or Pharmaceutical Engineering Experience: 15 to 20 years in sterile manufacturing plant operations, with a minimum of 10 years in a leadership role and at least 7 years in a regulated sterile manufacturing environment. About The Company Fresenius Kabi Oncology Limited, a wholly owned subsidiary of Fresenius Kabi, is a leading player in the oncology generics market with a broad portfolio that includes injectables, cytotoxic, and APIs. Its state-of-the-art production facility in Baddi features dedicated units for cytotoxic and non-cytotoxic products, including liquid and lyophilized injectables. The facility is approved by global regulatory authorities such as EMA, ANVISA, and Health Canada, and its products are registered in over 30 countries. About The Role As Site Head of the Baddi facility, you will oversee and be responsible for all aspects of site manufacturing operations. This leadership role is pivotal in ensuring operational excellence, regulatory compliance, and strategic alignment with the global oncology supply chain. You will be responsible for driving performance, fostering a culture of continuous improvement, and leading a cross-functional team toward sustainable and efficient operations. The potential candidates should be result-driven, resilient, collaborative and empathetic. About the Responsibilities Strategic Leadership: Lead the end-to-end operations of the sterile injectable plant, including production, quality, engineering, supply chain, and EHS functions. Regulatory Compliance: Ensure full compliance with internal and external regulatory standards (e.g., EU-GMP, WHO-GMP) and corporate SOPs. Operational Excellence: Drive continuous improvement in manufacturing efficiency, cost optimization, and product quality. Oversee the implementation of digitalisation, such as optical inspection and serialisation. People Management: Build and lead a high-performing cross-functional team. Foster a culture of accountability, safety, and innovation. Project Execution: Oversee capacity expansion, technology transfer, and commissioning of new lines (e.g., lyophilization, isolator-based filling systems). Stakeholder Engagement: Collaborate with corporate leadership, regulatory bodies, and cross-functional teams to align plant goals with organizational objectives.