The individual will be responsible for setting up and functioning of injectables and Oral Solid Dosage (OSD) formulation plant functioning. He will coordinate and liaise with various internal and external consultants right from design stage through construction, commissioning, and maintenance of the formulation plant. Candidate must possess in-depth understanding of formulation plant designs as per FDA and EU-GMP guidance / expectations. Candidate must have built Lyophilizers and Isolators based high potent compound-based formulation facilities preferably in both injectable and OSD or at least injectable for the regulated markets. Experience 12 to15+ years of experience with at least 5-6 years of experience in formulation manufacturing projects site execution . Location Indore Qualifications Diploma / B.E 12 to 15+ years of experience with at least 5-6 years of experience in formulation manufacturing projects design and site execution . ResponsibilitiesExperience in green field project management including design, construction, comprehensive validations and maintenance within cGMP norms with successful formulation project outcome. Preferably should have handled Steroidal-hormonal Or Oncology or other high potent compounds Formulation projects. Should have handled designing, construction, and commissioning of Lyophilizers and isolators-based injectable and or OSD plants for regulated markets. Experience in using Project Management Software and tools. Project scope definition, organization and planning. Coordination with External consultant / Engineers, agencies and in-house various Function heads. Project labor requirements and budget Protocol and SOP development, scheduling, and implementation He should have knowledge & experience of Injectable equipment’s like. Isolator, Washing, Filling sealing and packing equipment’s.The Engineer would be required to take care of Design of the facility & Day to day coordination of activities at site.Will be directly involved in Process equipment’s selection, documentation, and Utilities design and installation activities at site.Engineer would be required to take care of Design of the plant, HVAC, Water system and all major components of the manufacturing plant.Engineer is required to be well versed with Area classifications, Zoning, Differential pressures requirements, and containment’s of the pharmaceutical industry.Engineer would be required to directly interact with internal stakeholders (Production, QA, Safety, TTC etc) & external agencies (Consultants, PMC’s, Vendors etc). Engineer would be required to analyse & evaluate all the Drawings before release of same to site for execution.Will have to make & monitor daily progress records at site.Will also involve travelling to certain extent for various coordination meetings at Consultants office & Head office.Will have to travel to works of various suppliers for FAT’s & stage wise inspections as well.Will have to do the technical evaluation of the technical specifications of all components, coordination with vendors for supplies & documentations (DQ/IQ/OQ etc).Will have to coordinate with consultants & vendors for timely availability of drawings and details at site.Will have to maintain the complete records of drawings & documents released to site.He is required to have working knowledge of AutoCAD & Microsoft Project.He should be well versed with various standards of Mechanical Engineering, ASME & ASTMA guidelines.He should have knowledge & experience of Pharmaceutical Industry. Key Deliverables Directing and managing the suppliers, liaising with Quality team, gap identification and risk mitigation and abiding to scheduled deadlines. Complete familiarity and knowledge of cGMP, CAPA and SHE. Demonstrated success in managing plant processes Key Competencies Experience in managing injectables and oral solids plant. Directing and managing the research activities to scheduled deadlines Complete familiarity and knowledge of cGMP and GLP. Extensive understanding of the formulations manufacturing process. Good knowledge of regulated environment and cGMP. Personal attributes Individual with a proactive management style characterized by effective leadership, commitment, enthusiasm, communication and teamwork Ability to collaborate successfully with both internal and external stakeholders to achieve company objectives Self-motivated, team player and efficient problem solver
About the CompanyKnovea Pharmaceutical Pvt. Ltd. is looking for talented professionals to join our Quality Control team in Indore. Designation: Officer / Sr. Officer/ExecutiveExperience: 2 to 8 yearsLocation: IndoreIndustry: Pharmaceutical Manufacturing ResponsibilitiesCandidate must have handled analytical instrument such as HPLC, GC , UV, IR , KF, auto titrator, Polarimeter and LBPC instruments.Analyst shall be responsible for analysis of Raw Material, Packing material, finished product and stability samples.Candidate must have technical knowledge on QMS activities such as OOS,OOT, LIR, Deviation and change control management
Job Title: Process Incharge - Injectable Location: Indore Experience: 12-15+ years (5-6 years in formulation manufacturing projects) Review of equipment’s design qualification documents like PI&D, FS, DQ, SDS, HDS, IQ, OQ & drawings if applicable etc. and its approval if required. Process equipment instruments shall be verified as per PI&D and as per electrical drawings instruments commissioning shall be done if required FAT to be done for the process equipment’s if required. Support shall be given to installation & commissioning activities. To support qualification activities for the equipment’s like IQ, OQ & PQ All the process equipment and utilities equipment’s field instruments shall be identified by the team and schedule shall be prepared for calibration. Manage the instrumentation team for schedule calibration activities. Approve the calibration vendor for third party calibrations. Review of calibration certificates and its approval if required. Coordination with the vendors Spares indents, QMS elements like change control, deviations etc to be initiated and its approvals. To attend Equipment maintenances like preventive maintenance, breakdown etc. Preparation of SOP’s and its approvals. Interested candidates can share their CVs at nitin.shringi@knovea.com Show more Show less
Knovea Pharmaceutical Pvt. Ltd. is looking for talented professionals to join our Process Engineering (Instrumentation) team in Indore, MP. Designation: AM/DM/Manager No. of openings: 3 Experience: 8 years to 15 years Location: Indore, MP Industry: Pharmaceutical Manufacturing (Formulation injectable) Key Responsibilities: Review of equipment’s design qualification documents like PI&D, FS, DQ, SDS, HDS, IQ, OQ & drawings if applicable etc. and its approval if required. Process equipment instruments shall be verified as per PI&D and as per electrical drawings instruments commissioning shall be done if required FAT to be done for the process equipment’s if required. Support shall be given to installation & commissioning activities. To support qualification activities for the equipment’s like IQ, OQ & PQ All the process equipment and utilities equipment’s field instruments shall be identified by the team and schedule shall be prepared for calibration. Manage the instrumentation team for schedule calibration activities. Approve the calibration vendor for third party calibrations. Review of calibration certificates and its approval if required. Coordination with the vendors Spares indents, QMS elements like change control, deviations etc. to be initiated and its approvals. To attend Equipment maintenances like preventive maintenance, breakdown etc. Preparation of SOP’s and its approvals. If you’re passionate about engineering excellence and innovation, we’d love to hear from you!
Knovea Pharmaceutical Pvt. Ltd. is looking for talented professionals to join our Process Engineering (Mechanical) team in Indore, MP. Designation: AGM No. of openings: 1 Experience: 18 to 25 years Location: Indore, MP Industry: Pharmaceutical Manufacturing (Formulation injectable) Key Responsibilities: Review of equipment’s design qualification documents like PI&D, FS, DQ, SDS, HDS, IQ, OQ & drawings if applicable etc. and its approval if required. FAT to be done for the process equipment’s if required. Support shall be given to installation & commissioning activities. To support qualification activities for the equipment’s like IQ, OQ & PQ All the process equipment and utilities equipment’s shall be identified by the team and schedule shall be prepared for Maintenance. Approve the calibration vendor for third party calibrations. Review of calibration certificates and its approval if required. Coordination with the vendors Spares indents, QMS elements like change control, deviations etc. to be initiated and its approvals. To attend Equipment maintenances like preventive maintenance, breakdown etc. Preparation of SOP’s and its approvals. If you’re passionate about engineering excellence and innovation, we’d love to hear from you!
As a Process Incharge - Injectable, you will be responsible for overseeing formulation manufacturing projects with an experience requirement of 12-15+ years, including 5-6 years specifically in formulation manufacturing projects. Your key responsibilities will include reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval when necessary. You will be tasked with verifying process equipment instruments in alignment with PI&D and electrical drawings, ensuring commissioning of instruments as needed, and conducting Factory Acceptance Tests (FAT) for process equipment where necessary. Additionally, you will provide support for installation and commissioning activities and assist in the qualification of equipment through IQ, OQ, and PQ processes. Furthermore, you will collaborate with the team to identify all process equipment and utilities equipment field instruments, create calibration schedules, and manage the instrumentation team for calibration activities. You will also be responsible for approving third-party calibration vendors, reviewing calibration certificates, and coordinating with vendors for spares indents and Quality Management System (QMS) elements like change control and deviations. Your role will also involve attending to equipment maintenance tasks such as preventive maintenance and breakdowns, as well as preparing Standard Operating Procedures (SOPs) and obtaining necessary approvals. If you are interested in this challenging opportunity, please share your CV with us at nitin.shringi@knovea.com.,
Knovea Pharmaceutical Pvt. Ltd. is looking for talented professionals to join our Process Engineering (Mechanical) team in Indore, MP. Designation: AGM No. of openings: 1 Experience: 18 to 25 years Location: Indore, MP Industry: Pharmaceutical Manufacturing (Formulation injectable) Key Responsibilities: Review of equipment’s design qualification documents like PI&D, FS, DQ, SDS, HDS, IQ, OQ & drawings if applicable etc. and its approval if required. FAT to be done for the process equipment’s if required. Support shall be given to installation & commissioning activities. To support qualification activities for the equipment’s like IQ, OQ & PQ All the process equipment and utilities equipment’s shall be identified by the team and schedule shall be prepared for Maintenance. Approve the calibration vendor for third party calibrations. Review of calibration certificates and its approval if required. Coordination with the vendors Spares indents, QMS elements like change control, deviations etc. to be initiated and its approvals. To attend Equipment maintenances like preventive maintenance, breakdown etc. Preparation of SOP’s and its approvals. If you’re passionate about engineering excellence and innovation, we’d love to hear from you!
As a member of the Process Engineering (Instrumentation) team at Knovea Pharmaceutical Pvt. Ltd. in Indore, MP, you will play a crucial role in the pharmaceutical manufacturing industry. Your responsibilities will include: - Reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval if necessary. - Verifying process equipment instruments according to PI&D and electrical drawings for commissioning if needed. - Conducting FAT for process equipment as required and providing support for installation and commissioning activities. - Supporting qualification activities for equipment including IQ, OQ, and PQ. - Identifying all field instruments for process and utility equipment, preparing a schedule for calibration. - Managing the instrumentation team to carry out scheduled calibration activities. - Approving third-party calibration vendors and reviewing calibration certificates as necessary. - Coordinating with vendors for spares, initiating QMS elements like change control and deviations. - Attending to equipment maintenance tasks such as preventive maintenance and breakdowns. - Preparing SOPs and obtaining necessary approvals. If you are passionate about engineering excellence and innovation, Knovea Pharmaceutical Pvt. Ltd. welcomes you to join our team in Indore, MP.,
Department: Quality Designation: General Manager / Sr. General Manager Educational Qualification: B.Pharma/M.Pharma Experience required: 20 years to 25 years Job Description: Responsible for management of all aspects of Quality functions including Quality Assurance (QA), Quality Control (QC) and Validation (VD) at Site for the dosage forms at Knovea Pharmaceuticals. Define operational strategy & road map for Quality Management System and should be involved in all Quality related matters at site. Define Quality Assurance, Quality Control and validations department goals, objectives and strategy in line with compliance, product quality management objectives and regulatory requirements. Accountable for quality of products manufactured and released, monitor overall compliance at site. Proactively assesses quality issues and ensures compliance with QA, QC and Validation regulatory requirements in manufacturing operations and track quality assurance, quality control and validation department metrics with manufacturing operations at site and drive them. Ensure that the system is in place to release or reject raw materials, intermediates, packaging and labelling materials. Ensure that the executed batch production and laboratory records of critical process steps should be reviewed before the release of the finished dosage form for market distribution. Ensure that critical investigations are investigated and resolved. Managing investigations and impact/risk assessments for deviations concerning good documentation practices and potential data integrity issues. Taking leadership during any Data integrity observation investigation. Ensure that all specifications and master production records should be approved by QA. Ensure that all procedures impacting the quality of raw material, intermediates (if any), or dosage form should be approved by QA. Ensue that internal audits (self-inspections) are performed at site as per the SOP / schedule. Ensure system in place to approve intermediate, raw material and dosage form manufacturers by QA (if applicable). Ensure all aspects of the change control process that potentially impact raw material or dosage form quality as per the SOP of change control management. Ensuring that all validation and qualification efforts such as process validation, cleaning validation, equipment/facility qualification, and computer system validation are performed as regulatory and cGMP requirements.
As a Process Incharge for Injectable manufacturing projects, your role will involve reviewing equipment design qualification documents such as PI&D, FS, DQ, SDS, HDS, IQ, OQ, and drawings for approval. You will verify process equipment instruments according to PI&D and electrical drawings for commissioning. Additionally, you will conduct FAT for process equipment when necessary and provide support for installation and commissioning activities. Key Responsibilities: - Verify process equipment instruments based on PI&D and electrical drawings - Conduct FAT for process equipment when required - Provide support for installation & commissioning activities - Assist in qualification activities for equipment (IQ, OQ & PQ) - Identify all process and utilities equipment field instruments, and prepare a calibration schedule - Manage the instrumentation team for calibration activities - Approve calibration vendors for third-party calibrations - Review and approve calibration certificates as needed - Coordinate with vendors for spares indents, QMS elements like change control, deviations, etc. - Attend to equipment maintenance tasks such as preventive maintenance and breakdowns - Prepare SOPs and obtain necessary approvals Qualifications Required: - 12-15+ years of experience in formulation manufacturing projects - Minimum 5-6 years of experience in formulation manufacturing projects - Strong knowledge of equipment design qualification processes - Experience in managing calibration activities and vendor relationships - Familiarity with QMS elements like change control and deviations - Ability to prepare SOPs and ensure compliance with approvals If you are interested in this role, please share your CV at nitin.shringi@knovea.com.,