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16 Job openings at Zentiva Group, a.s.
Executive - Production, Pharma

Ankleshwar

5 - 6 years

INR Not disclosed

On-site

Part Time

Job Title: Executive – Production, Pharma Educational Qualification and Experience: M. Pharm / B. Pharm from a reputed university, having 5 to 6 years in pharmaceutical manufacturing in Granulation, compression, Coating, Primary and secondary packing sections. Production Implementing a monthly production schedule with consistent quality, adhering to Regulatory, GQS, and HSE guidelines, with proper utilization of resources and optimum cycle time. Performing the production activities in assigned areas to achieve 100 % customer service. Performing the SAP-related activities Able to handle a team consisting of Contractual persons, FTC & Operators in the allocated shift Able to do troubleshooting in the allocated area ISO 14001 and SAP Adhering to ISO 14001 activities and objectives in Pharma Mfg. Performing all the SAP-related activities as and when needed. Compliance Implementing and ensuring compliance with GQS, HSE, and ISO guidelines/standards and maintaining documentation for the same, including process validation and qualification. Coordination Coordinating with Engineering department for preventive and breakdown maintenance, modifications etc. The purchase department for procuring and controlling auxiliaries. Quality department for all quality-related matters. Packaging department for bulk availability. Yield monitoring Implementing and making efforts for the continuous improvement of the yield of assigned products Training Impart training to the operative staff (like contractual persons, FTC & operators ) on GMP, Data Integrity ,HSE, ISO requirement & process improvement and maintaining good industrial relation in the plant by effective grievance process. Others Carrying out any other assignments or projects like qualifications and validations as per the instruction of the Dept. Head to meet the organizational priorities. Identifying and correcting unsafe conditions or behavior and promptly reporting other potentially hazardous situations. Maintaining plant assets in good condition and making optimum use of all resources. Ready to work in each shift & in any allocated areas

Sr. Executive I - Production, Pharma

Ankleshwar

7 - 10 years

INR 1.929 - 4.175 Lacs P.A.

On-site

Part Time

Job Title: Sr. Executive – Production, Pharma Educational Qualification and Experience: M. Pharm / B. Pharm from a reputed university, having 7 to 10 years in pharmaceutical manufacturing in Granulation, compression, Coating, Primary and secondary packing sections. Production Implementing a monthly production schedule with consistent quality, adhering to Regulatory, GQS, and HSE guidelines, with proper utilization of resources and optimum cycle time. Performing the production activities in assigned areas to achieve 100 % customer service. Performing the SAP-related activities Able to handle a team consisting of Contractual persons, FTC & Operators in the allocated shift Able to do troubleshooting in the allocated area ISO 14001 and SAP Adhering to ISO 14001 activities and objectives in Pharma Mfg. Performing all the SAP-related activities as and when needed. Compliance Implementing and ensuring compliance with GQS, HSE, and ISO guidelines/standards and maintaining documentation for the same, including process validation and qualification. Coordination Coordinating with Engineering department for preventive and breakdown maintenance, modifications etc. The purchase department for procuring and controlling auxiliaries. Quality department for all quality-related matters. Packaging department for bulk availability. Yield monitoring Implementing and making efforts for the continuous improvement of the yield of assigned products Training Impart training to the operative staff (like contractual persons, FTC & operators ) on GMP, Data Integrity ,HSE, ISO requirement & process improvement and maintaining good industrial relation in the plant by effective grievance process. Others Carrying out any other assignments or projects like qualifications and validations as per the instruction of the Dept. Head to meet the organizational priorities. Identifying and correcting unsafe conditions or behavior and promptly reporting other potentially hazardous situations. Maintaining plant assets in good condition and making optimum use of all resources. Ready to work in each shift & in any allocated areas

Senior QA Specialist ESO

Ankleshwar

5 years

INR 2.51649 - 4.255 Lacs P.A.

On-site

Part Time

MISSION STATEMENT To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor. MAIN ACCOUNTABILITIES AND DUTIES Operational skills Operational quality management of a dedicated product portfolio which includes: Quality management of deviation and complaint records and their related CAPAs Assessment and management of change controls Edition of QA Agreements with Zentiva third parties and subcontractors Collection and evaluation of PQRs and stability data Compliance evaluation of Third Parties and products Maintenance of product database Collection and review of CoA/CoC QA support of product launches and transfers GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations Auditing Prepare audit and audit plans Conduct and participate to external audits Evaluation of audit reports Participate to internal audits and inspections KPI monitoring and reporting Other tasks may be performed under the direction of the Manager within the agreed type and scope of work. OTHER RESPONSIBILITIES QUALITY Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy. HSE Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System. PHARMACOVIGILANCE All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations COMPLIANCE The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents. REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS University degree in Pharmacy, Chemistry, Biology, or relevant Life Science Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements Management of subcontractors is an advantage Proven track record of project management skills Strong communication skills and negotiation strength Proactive attitude Problem solving skills Hands-on attitude, flexible and open minded Collaborative and team-spirited Knowledge of IT tools Language - English: Advanced level

Executive - QC (Chemistry)

Ankleshwar, Gujarat

2 years

Not disclosed

On-site

Full Time

JOB DESCRIPTION JOB TITLE Executive-I, Quality Control, Chemistry Country India Site / Unit Chemistry Ankleshwar Job Family / Sub Job Family Quality Operations Standard job Quality Control JOB PURPOSE Generic To perform QC activities in order to ensure quality of products and services and maintain related documentation to adhere to QO and regulatory requirements. All above activity shall be done living Group’s Values and Code of Ethics. Specific additions (if needed) N/A KEY ACCOUNTABILITIES 1.Analysis and approval Supporting in-process control sample testing by online analysis to support production activities in all 3 shifts Sampling, analysis and ascertaining quality of water, intermediates, In-process samples and API for Chemistry Ankleshwar. Testing of the method validation samples and process validation samples and cleaning validation. Perform analysis and documentation of API finished product stability study as per stability study protocol. Coordinating with Production, CWH and QA for Approval / Rejection of raw materials/finished product. Validation and verification of analytical procedures as per requirement. Reporting OOS / OOT results and deviations. Maintaining retained samples as per standard procedure. Assisting in investigation of customer complaint. Testing of new samples (Vendor approval) Give required suggestion for corrective actions and to plan effective preventive actions for the up gradation of the quality system. To ensure proper maintenance of the stability samples and their management. Disposal of waste according to the approved procedures. Continual reduction in the waste generation and effluent management. Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities. Documentation Generation, managing and archiving Documents including raw data, reports, COA etc as per requirements. Preparation and implementation of the SOPs in the laboratories system. Specification preparation and implementing for API raw material and API finished product according to requirement Maintaining LIMS data entries Providing technical support in compiling Annual Product Review. Analytical method development when required. 2.6.Executing on line documentation Laboratory Management Qualification and Validation of instruments/equipment Appropriate training and guidance to the subordinates. Safety in the laboratory. Regular housekeeping and upkeep of the work area. Maintaining adequate inventory of chemicals and reference standards. Adapting relevant technologies and systems in Quality control. Laboratory equipment calibration and their maintenance. Developing training modules for improvement / training for HSE and Quality systems Generate up gradation plans as need basis. Any other activity assigned by the In charge, Quality control Quality, HSE and Compliance Adhere to current GMP guidelines Following ALCOA+++ practices during documentation and related activities Compliance to local and international HSE norms Regulatory compliance ISO 14000 related activities Regular Pharmacopoeia and regulatory requirement review for compliance To participate in any regulatory/Customer inspection takes place at the site Training of self and subordinates on quality and HSE systems Team member Member of validation team. Member of Analytical transfer team. Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities. Other projects Trouble shooting activities. Participation in Industrial Excellence projects. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations Plant round in absence of QA and during IInd and IIIrd shift. Online checking of critical process parameters during round. REQUIREMENTS Education / Experience M.Sc. Analytical/Organic Chemistry/Inorganic Chemistry Min. 2 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment Technical skills & Competencies / Language Technical competence Leadership skills Analytical ability Planning ability Communication skills Problem solving Team Building Behavioural Competencies (LEAD and others) Leveraging group values ‘Accountability, Authenticity, Collaboration, Courage and Trust’ during day to day operations

Executive - Quality Control, Pharma

Ankleshwar, Gujarat

2 - 6 years

Not disclosed

On-site

Full Time

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Executive - Quality Control, Pharma

Ankleshwar

2 - 6 years

INR 2.22 - 7.275 Lacs P.A.

On-site

Part Time

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 2 - 6 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Executive - Quality Control, Pharma

Ankleshwar, Gujarat

5 - 8 years

Not disclosed

On-site

Full Time

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Executive - Quality Control, Pharma

Ankleshwar

5 - 8 years

INR 2.22 - 7.275 Lacs P.A.

On-site

Part Time

Position Title: Executive – Quality Control Qualification and Experience: M. Sc (Organic / Analytical Chemistry) / B. Pharm with 5 - 8 years of Experience as an analyst in the Pharmaceuticals / API industry. GMP & GLP knowledge Job overview: Implement quality control activities at Ankleshwar, adhering to regulatory/global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods, and other samples. Performing analysis of Stability, process validation samples, and Cleaning Validation. Handling of sophisticated laboratory instruments viz., HPLC, GC, UV & IR spectrophotometer, Dissolution tester, auto-titrator, polarimeter, etc. Good Laboratory Practice Performing calibration & maintenance of the lab. Equipment and assistance for the qualification of laboratory equipment. Knowledge on the preparation of SOPs and Formats and Analytical Test records. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining the record. Participating in the Investigation of out-of-specification results. Maintaining laboratory raw data related to testing activity. Validation Performing Analytical Method validation, cleaning validation as per the protocol. Other Coordinating with production and the warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Requirements GMP & GLP knowledge Good coordination & communication skills. Analytical ability Knowledge on LIMS & QMS What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location information: Ankleshwar, Gujarat, India

Sr. Executive - Production, Pharma

Ankleshwar

7 - 10 years

INR 2.15 - 5.6 Lacs P.A.

On-site

Part Time

Job Title: Sr. Executive – Production, Pharma Educational Qualification and Experience: M. Pharm / B. Pharm from a reputed university, having 7 to 10 years in the pharmaceutical Primary and secondary packing section, and also exposure in manufacturing in Granulation, compression, and Coating. Production Implementing a monthly production schedule with consistent quality, adhering to Regulatory, GQS, and HSE guidelines, with proper utilization of resources and optimum cycle time. Performing the production activities in assigned areas to achieve 100 % customer service. Performing the SAP-related activities Able to handle a team consisting of Contractual persons, FTC & Operators in the allocated shift Able to do troubleshooting in the allocated area ISO 14001 and SAP Adhering to ISO 14001 activities and objectives in Pharma Mfg. Performing all the SAP-related activities as and when needed. Compliance Implementing and ensuring compliance with GQS, HSE, and ISO guidelines/standards and maintaining documentation for the same, including process validation and qualification. Coordination Coordinating with Engineering department for preventive and breakdown maintenance, modifications etc. The purchase department for procuring and controlling auxiliaries. Quality department for all quality-related matters. Packaging department for bulk availability. Yield monitoring Implementing and making efforts for the continuous improvement of the yield of assigned products Training Impart training to the operative staff (like contractual persons, FTC & operators ) on GMP, Data Integrity ,HSE, ISO requirement & process improvement and maintaining good industrial relation in the plant by effective grievance process. Others Carrying out any other assignments or projects like qualifications and validations as per the instruction of the Dept. Head to meet the organizational priorities. Identifying and correcting unsafe conditions or behavior and promptly reporting other potentially hazardous situations. Maintaining plant assets in good condition and making optimum use of all resources. Ready to work in each shift & in any allocated areas

Sr. Executive - Perform Program

Ankleshwar

5 - 8 years

INR Not disclosed

On-site

Part Time

Job Title: Sr. Executive - Perform Program for Alternate Source implementation Qualification: Graduate / Post Graduate in Pharmacy with 5-8 years of experience in Pharmaceutical Quality Assurance or Production Candidate having sound experience in documentation as well as execution of oral solid dosage Production process starting from Dispensing to Secondary packing. 5-8 years of exposure either in Quality Assurance (IPQA, QMS) or Manufacturing/Production section including Manufacturing or packing section Specific Requirements: Experience in IPQA, QMS or Production activities of Solid Dosage Form (Tablets). Worked with EU regulatory-approved pants. Quality assurance (IPQA, QMS) Operating SAP/ERP and QMS tools (Trackwise, Quality forward) Compilation and Documentation of Pharmaceutical documents Communication, coordination, Tracking and Exposure to Shop floor Job Summary: Key member of Perform Program function in Site Strategy Execution team. Executive/Sr. Executive - Alternate Source implementation is primarily responsible to support Perform Program Manager for successful Planning and execution by ensuring end-to-end tracking and coordination of project activities identified for ongoing / new projects such as Product Transfer, New Development, Product supply switch, New product launch and alternate source implementation in line with Zentiva roadmap to deliver ‘on time in full’ commitments from LRP and budget by engaging relevant functions and operations in the organization. The role will be as well accountable to sustain overall tracking and coordination system (reporting and governance) established as a common way of working and measure across the various functions and sites involved. All above activities shall be performed in line with Zentiva’s compliance requirement (Quality and Safety). Strong communication and coordination skills within the team and cross-functional departments Process knowledge and awareness with Quality/QMS tools Knowledge of SAP and QMS tools (eDMS, Trackwise, Quality Forward) Compilation and documentation of Pharmaceutical documentation KEY ACCOUNTABILITIES Process Responsible to support Perform Program Manager by ensuring end-to-end tracking and coordination of Product Transfer, New Development, Supply switch, Launch and alternate supplier implementation activities for the site, to achieve timely project completion which can support growth.. Management of all identified project actions at site using project plan and to check their accomplishment for successful project execution. Participation and engagement with site as well as global project team beginning from Product feasibility, Technology transfer till launch/supply switch for the new development/internalize transfer products and alternate source implementation identified for the products concerned. Understanding communication of relevant information associated to projects received from the Development / Portfolio team to other cross functional team members of the technical team. Engaging project team members through regular calls and steering regular project team meetings across the respective organizational group. Responsible to Cooperates with site as well as external stakeholders, transfer team (both global and site) for identified projects, i.e. Product Transfer, New Development, COGs optimization and capacity utilization, Alternate supplier implementation, Product life cycle management and process optimization. Participating and actively managing regular, cross-functional Launch Management meetings, to ensure timely delivery of work packages of all involved stakeholders Effective and successful communication with all stakeholders Support continuous improvement activities by participating in cost engineering techniques and operational excellence techniques, identifying inefficiencies and cost optimisation opportunities. Other activities priority assigned by Perform Program Manager. Compliance Adherence to Zentiva Quality, HSE and organizational compliance Ensure timely completion of training in order to comply with Quality and HSE compliance across all levels Capture good practices across the organization (techniques, processes, management etc..) Share good practices across the organization Feedback to process / function owners the new standards requirement for future development of processes / products Monitoring and Improvement: Provides project updates and reports on project progress to both site as well as global management using Process flow Tracker or suitable project tracker established. Coordinating with Shop floor team members for Transfer project / source change related activities on the shop floor in production areas. Coordination and Follow-up with cross functional project team including Production, Quality, Warehouse – Supply chain, Procurement and Controlling according to the action items defined and maintain current status in the tracker. Preparation and timely revision of project-related documentation and databases, e.g. Product Transfer checklist, Product transfer Protocol and Report and other project related documentation. Initiating, Tracking and management of Project related Change controls, actions identified, Extension of the change control actions as well as closure. Ensuring availability of Supplier documentation and other prerequisites for new API/RM required for respective project. Coordination with responsible for ZMID, BOM and material sourcing (PR/PO tracking) and other associated activities for Projects Periodic reporting of KPIs defined Report / track project achievement/challenges to identify any actions required.

Executive - Quality Assurance, Pharma

Ankleshwar

1 - 4 years

INR 2.51649 - 4.255 Lacs P.A.

On-site

Part Time

Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit. Quality Management/Continuous Improvement Line Clearance and shop floor compliance Assisting in Complaint Investigation system at site Assisting in Qualification and validation system, change control system, deviations Preparing & review the Annual Product Quality Review Review of Batch Manufacturing & Packing Records Coordination of cGMP Training activity. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications: Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes Review of protocols for qualification and validation of facility/ equipment / product / process Review of validation reports after execution of validation of facility /equipment / product / process Documentation Control: Preparation and Review of SOPs Controlled distribution and archival of documents & record Control of master documents Assuring quality of products by : Ensuring SOP compliance Review of Batch Manufacturing & Packing Records Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints Ensuring the effectiveness review of the implemented CAPA cGMP Training: To prepare training modules and organize training in GMP Execute the training program in coordination with all concerned departments Other: Review of maintenance and calibration program

Executive - Quality Control, Pharma

Ankleshwar, Gujarat

2 - 5 years

None Not disclosed

On-site

Full Time

Position Title: Executive – Quality Control, Pharmaceuticals Job overview: Implement quality control activities at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analysis of Stability, process validation samples, Cleaning Validation. Good Laboratory Practice Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. Validation Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol. Management of laboratory Consumables Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. Other Coordinating with production, and warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities. Requirements & Qualifications: M.sc (Organic / Analytical Chemistry) / B. Pharm with 2-5 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills. What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location Information: Ankleshwar GIDC District: Bharuch State: Gujarat.

Executive - Quality Control, Pharma

Ankleshwar

2 - 5 years

INR 2.22 - 7.275 Lacs P.A.

On-site

Part Time

Position Title: Executive – Quality Control, Pharmaceuticals Job overview: Implement quality control activities at Ankleshwar adhering to regulatory / global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements. Responsibilities: Analysis: Performing timely sampling and analysis of raw material, bulk product, intermediates, finished goods and other samples. Performing analysis of Stability, process validation samples, Cleaning Validation. Good Laboratory Practice Performing calibration & maintenance of lab. Equipment and assisting for the qualification of laboratory equipment. Preparing SOPs and Formats and Analytical Test Record. Managing reference standards, working standards, laboratory reagents & chemicals. Arranging and observing Control Samples and maintaining record. Participating in Investigation of out of specification results, retesting and review the analysis records. Maintaining & reviewing laboratory raw data related to testing activity. Validation Preparing protocol for Analytical Method validation, cleaning validation and performing the validation exercise as per the protocol. Management of laboratory Consumables Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, spares, glassware and printed material. Other Coordinating with production, and warehouse for analytical activities Compliance to HSE Requirements for QC laboratory. Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities. Requirements & Qualifications: M.sc (Organic / Analytical Chemistry) / B. Pharm with 2-5 years of Experience as an analyst in similar industry GMP & GLP knowledge Good coordination & communication skills. What makes this position unique? This position will provide good exposure to work in GMP/ GLP environment. Location Information: Ankleshwar GIDC District: Bharuch State: Gujarat.

Assistant Manager - Plant Engineering, Pharma Formulations

Ankleshwar

8 - 10 years

INR 2.7 - 6.025 Lacs P.A.

On-site

Part Time

Job Title: Assistant Manager - Plant Engineering Plant Maintenance – Pharma Formulations Basic & Minimum Qualification Degree in Mechanical / Instrumentation Engineering Experience: 8 to 10 years of working experience in a Pharmaceutical Formulations plant. Location: Ankleshwar Site. Job Description and KEY ACCOUNTABILITIES Responsible for troubleshooting and breakdown maintenance of packing equipment (Blister packaging and cartonator, serialization machines), and minimizing equipment downtime. Corrective & Preventive maintenance to eliminate recurring failures in the equipment. Execution of monthly / Quarterly, and Annual Preventive maintenance of the equipment and operating the same to achieve the target of 100% completion against the scheduled Preventive Maintenance of the equipment. 100% Equipment Qualification of plant equipment, facilities and Re-qualification of Critical equipment as decided by the site validation Forum. Documentation and maintaining the History cards of all critical plant equipment. Preparation and implementation of standard operating procedures for Plant Engineering operations and documentation of the same. Spare parts management – Responsible to procure spare parts and maintain stock for all packing & critical equipment. Troubleshoot and resolve mechanical and automation-related issues in packing machines to reduce downtime. Support continuous improvement initiatives (Kaizen, OEE enchantement, RCA, MTTR & MTBF, etc.) Responsible for complying with suggestions given by the HSE Cell. Responsible for complying with recommendations made by the internal GMP cell Responsible for the implementation of GMP and EH&S requirements for PHARMACEUTICALS. Identifying and correcting unsafe conditions or behaviors, and promptly reporting other potentially hazardous situations. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Baseline Capex & Identified building expansion projects execution from Planning, engineering execution, validations, qualifications, documentations, etc., complete. Collect, analyze, and interpret data related to the supply chain, including inventory levels, demand forecasts, supplier performance, transportation costs, and production efficiency. Budget management: Tentative management of 200 to 300 K€ Technical Skills & Competencies / Language Basic Knowledge of AutoCAD or Microsoft Project Interpersonal Skills Communication Skills Cost consciousness Innovations/creativity SAP and other e-tools Microsoft Excel Co-ordination. Adherence to HSE requirements in fulfilling the customer’s requirement, Living Group’s Values, and Code of Ethics.

Executive I - Production, Pharma

Ankleshwar, Gujarat

2 - 5 years

None Not disclosed

On-site

Full Time

Job Title: Executive – Production, Pharma Educational Qualification and Experience: M. Pharm / B. Pharm from a reputed university, having 2 to 5 years in the pharmaceutical Primary and secondary packing section, and also exposure in manufacturing in Granulation, compression, and Coating. Production Implementing a monthly production schedule with consistent quality, adhering to Regulatory, GQS, and HSE guidelines, with proper utilization of resources and optimum cycle time. Performing the production activities in assigned areas to achieve 100 % customer service. Performing the SAP-related activities Able to handle a team consisting of Contractual persons, FTC & Operators in the allocated shift Able to do troubleshooting in the allocated area ISO 14001 and SAP Adhering to ISO 14001 activities and objectives in Pharma Mfg. Performing all the SAP-related activities as and when needed. Compliance Implementing and ensuring compliance with GQS, HSE, and ISO guidelines/standards and maintaining documentation for the same, including process validation and qualification. Coordination Coordinating with Engineering department for preventive and breakdown maintenance, modifications etc. The purchase department for procuring and controlling auxiliaries. Quality department for all quality-related matters. Packaging department for bulk availability. Yield monitoring Implementing and making efforts for the continuous improvement of the yield of assigned products Training Impart training to the operative staff (like contractual persons, FTC & operators ) on GMP, Data Integrity ,HSE, ISO requirement & process improvement and maintaining good industrial relation in the plant by effective grievance process. Others Carrying out any other assignments or projects like qualifications and validations as per the instruction of the Dept. Head to meet the organizational priorities. Identifying and correcting unsafe conditions or behavior and promptly reporting other potentially hazardous situations. Maintaining plant assets in good condition and making optimum use of all resources. Ready to work in each shift & in any allocated areas

Assistant Manager - Quality Assurance, Pharma

Ankleshwar

8 - 10 years

INR Not disclosed

On-site

Part Time

Job Title: Sr. Executive / Assistant Manager – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 8 to 10 years of similar experience in a regulatory-approved OSD manufacturing large unit. Job Responsibilities & Accountabilities: We are looking for an experienced QA professional to join our team and lead Deviation & Complaint Investigations, along with core QMS activities. Key Responsibilities: Lead deviation and market complaint investigations, with timely CAPA execution Ensure effective implementation and tracking of CAPAs from deviations & complaints Review Batch Manufacturing & Packing Records, APQR, and SOPs Manage Change Controls, Validations/Qualifications, and QMS documentation Conduct regulatory gap assessments and support compliance plan execution Coordinate GMP training, documentation control, and audit readiness What We’re Looking For: 8–10 years of QA experience in pharmaceutical manufacturing (formulations) Strong understanding of cGMP, investigation tools, and regulatory expectations (USFDA, MHRA) Skilled in QMS systems. Excellent documentation, analytical, and coordination skills

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