MISSION STATEMENT The role of Quality Operation Manager is to manage team of QA specialists responsible for full quality lifecycle maintenance of dedicated product portfolio. Lead the QA specialists, define QA standards (way of working), identify and escalating gaps within the quality management system and proposing solution. Main Accountabilities And Duties Manage a team of QA Specialists responsible for the full quality lifecycle activities of dedicated product portfolio.Be the responsible quality representative and the main point of contact for quality related matter for subgroups (hubs) of subcontractors and third parties.Support and assure appropriate quality oversight into processes and over CMOs in scope of responsibility (hubs) to ensure product quality and compliance of activities performed at CMOs.To assure that activities connected to assigned hubs will be managed according to defined plans, processes and KPI.Supervision of selected processes such as (but not limited to): Management of deviation/non-conformities, complaints and related CAPAs managed in a compliant and timely manner Support preparation, participation and lead of escalations Compliance evaluation of Third Parties and products Edition, review and approval of QA agreements Management of CoA/CoC collection and review Review and issuance of PQRs / Stabilities data Training status of team members Definition of objectives Appropriate and timely reporting of KPIsSupport auditing activities: Prepare audits and audit plans Conduct, participate, lead external audits Evaluation of audit reports Participate to internal audits and inspections Creation of internal proceduresParticipate on project linked to the portfolio lifecycle management and optimizations. Supervise ordering of additional quality services at subcontractors and third parties as required and to assure correct invoice managementOther tasks may be performed under the direction of the Manager within the agreed type and scope of work. Required Qualifications, Experience & Skills University degree in Pharmacy, Chemistry, Biology, or relevant Life ScienceMinimum of 8 years in a similar role or equivalent experiences in a GMP related environmentMinimum of 2 years in a people management positionThorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirementsManagement of subcontractors is an advantageProven track record of project management skillsStrong communication skills and negotiation strengthSense of urgency, high autonomy & agile personalityProactive attitudeProblem solving skillsHands-on attitude, flexible and open mindedCollaborative and team-spiritedKnowledge of IT toolsLanguage - English: Advanced levelProblem solving skills

Job Description for Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 3 to 5 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

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

Job Title : Manager / Sr. Manager, Quality Control. Qualification: Post Graduate in Science (Organic or Analytical Chemistry ) with 12 to 15 years of experience. Job Summary Plan and implement Quality Control activity adhering to Zentiva Quality Guidelines, local FDA regulations, and HSE guidelines, leading a team of subordinates with optimum utilization of resources in order to ensure consistent good quality of products to meet with the GMP standards and customers’ requirements, living the Group’s Values and Code of Ethics. Strong leadership Analytical ability Interpreting skills Leadership Knowledge of cGLP & Regulatory Guidelines Modern QC instrumentation Techniques Communication Interpersonal Relationship Excellent problem-solving, decision-making, and organizational skills. Key Accountabilities Quality Design & Implementation of cGLP for Pharmaceutical laboratory ensuring compliance with Global Quality guidelines, local FDA (Schedule M & L) and other regulatory requirements of importing countries and Zentiva Quality standard. Ensure analytical method validation and transfer. Responsible for review and approval of SOPs, recording formats, test methods - specification, validation protocol / report, qualification and calibration of record of laboratory equipment, OOS/OOT/deviation investigation and re-analysis/fresh analysis decision, management of reference standards, Retained sample Management and training on GLP. Ensure the maintenance of laboratory premises and equipment. Manage Pharmaceutical laboratory activities by organizing / planning of sampling, testing, Qualification, Validation, Calibration, maintenance and related documentation. Participate in failure investigation, to carry out root cause analysis of failure /market complaints if any. Maintain change control, deviation & CAPA system. Responsible for reviewing the testing raw data, log book and related documents. Testing Organize and ensure timely sampling and testing of Chemical, Microbiological and Physical analysis of RM/PM, intermediates, finished goods and other samples for Pharmaceuticals. Also ensure timely analysis of stability samples, market complaints, process validation, cleaning validation and environmental monitoring samples. Ensure the monitoring of the stability of the products & stability section. Approval / Rejection of Raw Materials, Packaging Components and in process material. Extend testing support for Microbial testing & stability sample management of API / PD products / intermediates. Out Of Specification/ Out Of Trend Results investigations. Organize trending of QC analytical data as a part of Statistical Quality Control. To approve and monitor any contract laboratory. Organizing calibration / maintenance / qualification of laboratory Equipment and laboratory area. Organize collection and storage of Retention samples. HSE / IMS / GMP / GLP Implement the HSE and GMP norms, adherence to compliance, training and corrective actions in order to ensure that there is no deviation from the Zentiva standards and statutory HSE and GMP / GLP norms. Implement the system of working established as per IMS / ISO requirements in the Quality Operations department. Organizing and maintaining the health, safety and environmental management system. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations. Reviewing pharmacopeias and change control evaluation. Compliance Ensure compliance with FDA regulations; interact with local and State FDA authorities for Pharmaceuticals function requirements. Performing internal quality audit as well as third party GMP audit as a “Qualified Auditor” during Quality Audit abiding the audit schedule. Training, People Management, and Industrial Relations Train team members for laboratory-related jobs and evaluate for individual development. Monitoring good industrial relations in the department. Coordination Coordinate with purchase, warehouse, and production for planning and for vendor evaluation & development, for Technical Agreement Evaluation, Supplier Testing Approval, Audits of supplier- Contract Labs. Preparation and submission of laboratory documents for registration, for technical and liaison support respectively. Other Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities. Organizing and planning requirements for laboratory consumables and monitoring the stock of chemical, glassware, standards, and other related items. Show more Show less

Title of Position Executive – Warehouse, Pharma Basic & Minimum Qualification Graduate in Science / Commerce /Pharmacy and Diploma in Materials Management preferable. Experience 2 to 5 Years of relevant experience in the pharmaceutical warehouse Location: Ankleshwar Site. Job Description And Key Accountabilities Receipt & Issue of RM/PM and Dispatch of FG Plan and execute activities related to receipt & Issue of raw and packing materials and Dispatch of Finished Goods as per SOP with optimum utilization of resources. Co-ordinate Co-ordinate with Finance, Quality, Supply chain, and Procurement and execute necessary steps involved in receipts viz, making of GRNs, Sampling, PO amendments & PO release, etc. Co-ordinate with the Engineering Dept. for Equipment maintenance & other related activities for a smooth-running warehouse. Warehouse Maintenance Implement global warehousing standards and ensure compliance for GMP and HSE requirements. Initiate engineering-related work orders in HANA and ensure all get done on time to time. Carry out day-to-day maintenance of GMP documents/logbooks and formats as applicable. Statutory Compliances Ensure compliance with statutory audit requirements and physical stock verification. Material Planning Maintain the material receipt area to achieve continuous flow of incoming materials. Track the receipts as per the delivery schedule provided by the Supply chain. Coordinate with the supplier and approve the delivery schedule. GMP requirements Carry out day-to-day cleaning and housekeeping activities as per the SOP. Other Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations. Carry out destruction of old Warehouse records as per SOP and perform fixed assets mgmt. Ensure entire activities related to scrap management and maintain the required document/logbooks. Carrying out any other assignments or projects as per the instructions of the Department. Head to meet with the organizational objectives and priorities. Technical Skills & Competencies / Language SAP Microsoft Excel Good communication skills Show more Show less

Key Accountabilities Operational effectiveness Oversee, administrate, manage and communicate the operations and maintenance of owned application portfolio. Take responsibility for the technical solution of incidents in area of expertise, reacting quickly to limit impacts and resolve the issue. Prioritize individual incidents and ensuring the delivery of solutions in line with the operational level agreements to deadlines and quality standards. Involve in installation of new or transferred machine. Work on tracing the missing serials in batch, missing batches on Tracelink portal or EU hub, or customer portal. Involve in extended global serialization support as and when required. Communicate with other plants of Zentiva for common issues. Support in Tracelink where serialization reports the data, investigate in the issues where batch not reported to Tracelink or any issue in reported data. Communicate with vendor, and different internal teams (inside & outside Zentiva) to resolve the issues. Customer Relationship Provide technical advice and troubleshooting for owned application portfolio. Help customer to find out the flaws in serialization, PLC process, by observing and analyzing against the existing issues. Cross-training and presentations for colleagues and business key users Delivering user guides and support documentation to business key users Ensure customer satisfaction with owned application portfolio and propose enhancements based on customer requirements Project Contribution Implementation of serialization applications as part of TSA exit. Work with business and export team for execution of projects like iVEDA. Coordinate local activities and deliveries for projects like with local business key users. Involve in projects like PLC , Historian, etc. Requirements Education / Experience BE with 8 to 10 years related experience Technical Skills & Competencies / Language Service Level Management Design Architecture Technology Watching Design and Development Systems Integration Solution Deployment User Support Change Support Service Delivery and Problem Management Personnel Development Risk Management Act for change Strive for results Make decisions Commit to customers Cooperate transversally Show more Show less

MISSION STATEMENT We are a Corporate quality team governing major and critical quality incidents requiring escalation - we drive the assessments of quality issues raised within Zentiva product supply and commercial operation to ensure appropriate escalation, notification, categorization, mitigation, and health authority reporting, as well as consistency in assessment and documentation for all quality incidents. Our team is in liaison between quality and commercial / business stakeholders to ensure satisfactory management of quality issues. We ensure implementation of corporate quality system requirements , tools and procedures at affiliate quality management systems (QMS) including its evaluation, as well as communication and training within Zentiva organization. Main Accountabilities And Duties Key point of contact for information on escalation process and determination of issue criticality and categorization of issues, subsequent steps, and mitigating actions. Identifying stakeholders for discussion and decision making incase of escalations and manage the escalation meeting including the issuance of meeting minutes. Develop and maintain Guidelines / SOPs for escalation management including templates for investigation report, presentations, meeting minutes, and HA notifications. Ensure event record is raised, maintained, and completed in a timely manner meeting Good Documentation Practices and per processes for incidents in scope escalation management team. Update the organization with new regulations / requirements applicable to Genotoxic Impurities (Eg. Nitrosamine Impurities) and oversees the activities within Quality organization. Coordinates review and approvals of procedures, methods, analytical method validations with external or internal laboratories, risk assessments, investigation reports, change requests, etc with respect to Nitrosamine Impurities. Standardize the management of Genotoxic impurities management and improvise if needed. As an escalation process SME, drive timelines for process steps. Lead and manage Health Authority reporting as needed to ensure reporting is completed in a compliant manner. Support completion of monthly escalation updates on escalations (incidents). Develop and maintain a network of key stakeholders in Zentiva to ensure appropriate input and support of quality issues. Lead active surveillance and analysis of emerging regulations, suspension of EU GMPc & warning letters, perform impact assessments and drive process changes required to ensure ongoing compliance to regulatory requirements. Analyze the impact of other Zentiva processes and organizational changes on assigned processes. Develop and maintain Guidelines / SOPs for regulatory surveillance process. Assess and comment escalation before communication to target markets authorities and customers. Assure assessment and benchmark of similar cases among sites and affiliates to minimize duplicity in investigation and improve overall effectiveness. SME and provide support in case of authority inspections at market level. Prepare regular reporting in respective area. Establish KPIs and ensure KPIs are met for escalation (Genotoxic & other escalations) and for Regulatory Surveillance. 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 rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents. SUSTAINABILITY: Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet. MANAGERIAL POSITION REQUIREMENT: Good communication and adaptability to different portfolio projects and acquisitions, leadership of transversal teams in quality, participation in transversal project/acquisition teams, good planning, quick learning, broad quality knowledge, systematic tracking. Required Qualifications, Experience & Skills Technical University Degree (health, pharma, technical, chemical areas are advantage). 10+ years industry experience specifically in GxP with a strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable. Strong experience in area of GxP related to change control, deviation, quality processes and document management. Organizational and analytical skills associated with a proficiency in quality management and continuous improvement. Critical thinking ability and risk management and risk- based knowledge and approach. Ability in partnering with a proactive and solution- oriented approach. Strong skills to facilitate/optimize contribution of team members as individuals and members of a quality function. Ability to work effectively in a matrix cross-functional environment. Strong capacity for working independently with minimal supervision. Ability to make & communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking). Self-awareness, willingness to further develop own strengths and explore opportunities for improvement. What Is In It For You An opportunity to work for a successful international pharmaceutical company. An opportunity to learn newest approaches in managing creative and highly adaptive business organizations. Pleasant and dynamic working environment. Continuous personal development. An attractive compensation & benefits package. Above standard social and benefit program. Show more Show less

Job Description For Executive – Quality Assurance, Pharma Educational Qualification B. Pharm / M. Pharm from a reputed university Experience 3 to 5 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 Qualifications 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 Show more Show less

Title of Position Assistant Manager- Controlling – Chemistry at Ankleshwar Site Basic & Minimum Qualification Any Graduate with 4 -5 Years of experience in Finance & Controlling Experience 4 to 5 Years of relevant experience in the pharmaceutical / Chemical / API industry. Location: Ankleshwar Site. Job Description And KEY ACCOUNTABILITIES Periodic Reporting and analysis Preparing monthly managerial EBITDA for Site with comparison of Budget/LE/LO with qualitative commentary to update management & site leadership team for awareness to support achieving organization objective. Monthly MIS with details review of EBITDA, Inventory , Expenses, Capex , Productivity with rolling forecast. Reporting Board & any other ITS tool with reconciliation of actual, budget & forecast with proper control record. Economic Evaluation Providing assistance in Analyzing and evaluating the proposal for new products and projects, and impact of process change on product cost and capacity. Business Plan (LRP) Compiling, Consolidating & Preparing site business plan with due analysis. Preparing of standard Cost along with trend analysis. Monitoring the progress of business plan execution , Std Cost Calculations for budgeted & any New SKU’s Sourcing case with multiple scenario for Business analysis. Coordination Support site controlling in monitoring CAPEX / OPEX by required tracking of budgets & analysis of AEDs to ensure compliance of Group financial policy. Providing support and guidance to other cross-functional teams. Other Preparing and submitting data for cost audit & Balance Sheet, Group information. Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities. Identifying and correcting unsafe conditions or behaviors and promptly reporting other hazardous situations Internal collaboration with team with harmony & showing interest in developing leadership skill. Technical Skills & Competencies / Language Fundamental knowledge of costing. Handling Internal / Statutory audits. SAP and other e-tools. English speaking is must. Microsoft Excel / Power point / Power BI / BW Report. Communication Co-ordination. Education / Experience MBA Finance / Cost accountant with 4-5 years of experience . Behavioral Competencies (LEAD and others) Accountability, Authenticity, Collaboration, Courage and Trust Show more Show less

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 Show more Show less

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 Show more Show less

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 Show more Show less

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 Qualifications 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 Show more Show less

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

Key Accountabilities Analysis and approval Supporting in-process control sample testing by online analysis to support production activities Sampling, analysis and ascertaining quality of 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) Training of subordinates 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. Providing technical support in compiling Annual Product Review. Analytical method development when required. 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 Analytics. Laboratory equipment calibration and their maintenance. Generate up gradation plans as need basis. Any other activity assigned by the In-charge, Analytics 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. Participating in discussions and giving feedback to Manager, Analytics 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. Organic 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 Show more Show less

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 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 Show more Show less

Key Accountabilities Analysis and approval Supporting in-process control sample testing by online analysis to support production activities Sampling, analysis and ascertaining quality of 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 Show more Show less

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

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 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 Show more Show less

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 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 Show more Show less