4 Lyophilizers Jobs

Experience: 11 to 15 years Education: BE Designation: Sr. Executive- E3 Budget: Upto 15 LPA Nego Key Role: Process & Water System Lead: Job Description: Hands on experience on injectable process equipment like Vial filling lines, PFS filling lines, Isolators, Lyophilizers, and Steam Sterilizers maintenance and ability to lead team of 5-10 members. Candidate should have good exposure to Water Systems. Implementation and review of departmental documentation, validation & QMS activities. Shall have Hands-on experience on Change Control Management, Investigations & CAPA modules. Tracking allocated QMS task completion and closer within time. Analysis of breakdown notifications. Planning and execution of SAP preventive maintenance and timely closure. Maintaining and procurement of critical spare parts. Should be innovative, self-starter and work within the allocated budget. Focus on reverse engineering. Develop and coordinate with external vendors for and developing of indigenous spare parts and maintenance activities. Lead continuous improvement initiatives in the filling lines to increase process efficiency, energy conservation and capacity while maintaining a high level of quality. Ensure compliance to cGMP and quality system. Having exposure to face the regulatory auditors like USFDA, MHRA, ANVISA and TGA etc. Prepare the budget and capex for the engineering department and monitoring of yearly expenditure of engineering department. Ensuring compliance of safety policies, safe work environment for all the team members, external party, contractors etc. Legal compliance with respect to safety & environment, licensing with government authorities. If interested Mail cv at :- NeetiJ@selectsourceintl.com

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,

Role & responsibilities • You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents. • Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems. • You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test). • You will review and compile raw data, relevant certificates, analysis test reports and • preparation and review of final summary report. • You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation. • Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval. • You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification. • As part of your role, you will prepare and review VMP (Validation Master Plan). • You will conduct training for employees and external vendors as a qualified trainer. • Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label. • You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment. • You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Role & responsibilities Utility Executive : 1. Responsible for Operation, Maintenance of Block Utilities & Central Utilities.. 2. Responsible for ordering, maintain stock of spares, consumables required for the machines & facility. 3. Responsible for implementation of Preventive Maintenance activities as per schedule. 4. Execution of Qualification documents. 5. Preparation of SOPs and reviewing of daily log sheets. 6. Responsible for Change Controls & Deviations. 7. Responsible for breakdown analysis &CAPA. 8. Responsible for Energy conservation in Utilities. 9. Responsible for up gradation in utility systems. 10. Responsible for minimising break downs & Improving efficiency of utility systems & equipments. Instrumentation Executive : 1.Responsible for Operation of Lyophilizers. 2. Responsible for Preventive Maintenance of Lyophilizers. 3. Responsible for history records & service cards. 4. Responsible for breakdowns of Lyophilizers. 5. Planning & execution of Anticancer block all lines instrumentation electronics activities. 6 .Execution of Qualification documents. 7. Packing hall machinery Instrumentation Preventive, Breakdown & Major activities maintenance 8. Responsible for Preventive maintenance and breakdown of utilities equipments. 9. Responsible for data backup activitys for computerized systems (Engineering scope). 10. Responsible for preparation and Execution of IQ, OQ & IOQ documents. 11. Responsible for preparation VMP Annexures.