97 Deviation Jobs - Page 3

Job Title: Manager/Senior Manager QA Regulatory Affairs Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 8-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: M.Sc in Biotechnology, Microbiology, or a related field Bachelor’s or Master’s in Pharmacy Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager/Senior Manager – QA Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (QA) standards. You will oversee regulatory strategies, regulatory audits, and the management of Quality Management Systems (QMS) to ensure our products comply with industry-specific standards. This role demands extensive experience in regulatory affairs , particularly within the vaccine and sterile manufacturing domains, including handling CDSCO , EU GMP audits, and other regulatory matters. Key Responsibilities: Regulatory Strategy & Compliance: Develop and execute regulatory strategies to ensure compliance with global standards for vaccine , injectable , and sterile products . Maintain a strong understanding of global regulatory requirements, including FDA , EMA , WHO , and local regulations like CDSCO to guide product approvals and market entry. Ensure alignment of product development and manufacturing processes with Good Manufacturing Practices (GMP) , Good Laboratory Practices (GLP) , and other relevant GxP standards. Audit & Inspection Management: Coordinate and manage regulatory audits (e.g., CDSCO , EU GMP ) for vaccine , injectable , and sterile products, ensuring full compliance and readiness across all departments. Lead the preparation for regulatory inspections related to CDSCO and EU GMP , working closely with relevant teams to ensure effective corrective actions and continuous compliance. Manage responses to audit findings and ensure the implementation of corrective actions in line with industry standards. Quality Management System (QMS): Oversee the implementation and management of the Quality Management System (QMS) to ensure product quality and regulatory compliance. Lead the development and review of Standard Operating Procedures (SOPs) , ensuring that they align with current regulatory requirements for vaccine and sterile product manufacturing. Monitor and ensure compliance with the QMS framework across all departments to maintain consistent product quality. Regulatory Submissions & Documentation: Oversee the preparation, compilation, and submission of regulatory dossiers and eCTD documents to regulatory bodies (e.g., FDA , EMA , CDSCO ). Ensure that all required documentation and records are properly maintained and comply with regulatory standards, ensuring smooth regulatory approvals for vaccine , injectable , and sterile products . Risk Assessment & Mitigation: Conduct regulatory risk assessments to identify potential issues related to product development, manufacturing, and compliance. Develop and implement risk mitigation strategies to ensure uninterrupted production and compliance with regulatory standards. Cross-Functional Collaboration: Collaborate with internal teams such as R&D, Production, and Quality Control to ensure regulatory compliance throughout the product lifecycle, from development to post-market surveillance. Provide regulatory guidance and training to cross-functional teams, ensuring awareness of applicable QA practices and regulatory requirements . Corrective and Preventive Actions (CAPA): Lead the implementation of Corrective and Preventive Actions (CAPA) to address audit findings, non-conformities, and deviations, ensuring continuous improvement in compliance and quality practices. Key Skills and Competencies: Expert Knowledge of Regulatory Guidelines : Extensive knowledge of global regulatory requirements (e.g., FDA , EMA , WHO ) with specific expertise in vaccines , injectables , and sterile product manufacturing . Regulatory Submissions & Documentation Expertise : Strong experience in preparing regulatory dossiers and eCTD submissions in compliance with regulatory standards for vaccines and sterile products . Audit & Inspection Management : Hands-on experience managing CDSCO and EU GMP audits, including preparing for inspections, addressing findings, and implementing corrective actions. Quality Management System (QMS) Oversight : Expertise in implementing and maintaining QMS in compliance with GxP , FDA , EU , and WHO guidelines, ensuring product quality and regulatory compliance. Risk Management & Mitigation : Proven ability to conduct regulatory risk assessments and implement mitigation strategies to prevent non-compliance and product issues. Strong Leadership & Project Management : Demonstrated ability to lead cross-functional teams, manage multiple projects, and meet regulatory deadlines while ensuring alignment with quality and regulatory expectations. Corrective & Preventive Action (CAPA) Implementation : Experience in managing CAPA processes, addressing non-compliance issues, and ensuring the effective resolution of audit findings and regulatory observations. Excellent Communication Skills : Strong verbal and written communication skills, with the ability to liaise with internal teams, regulatory bodies, and external stakeholders in a professional and clear manner. About GreenSignal Bio Pharma Pvt Ltd: GreenSignal Bio Pharma Pvt Ltd is a leading pharmaceutical company specializing in vaccine , injectable , and sterile products . Our commitment to quality, compliance, and innovation has made us a trusted partner in the healthcare industry. We are looking for experienced professionals to contribute to advancing our vaccine and biologics portfolio while adhering to the highest regulatory standards. For more information, please visit: www.gsbpl.com How to Apply: Interested candidates can apply via email at: hr@gsbpl.com For inquiries, please contact us at: +91 8778926365 Join Our Team and make a significant impact in the vaccine and sterile product industries

Should have 3-7 years’ experience in Quality control Testing of Raw materials and Finished products Testing of stability samples Handling of HPLC & GC instruments Handling of Chromeleon software Handling of UV, TOC, FTIR & Auto titrator instruments Instrument calibrations & trouble shooting Handling of LIMS Should have knowledge on GMP/GLP Should have knowledge on OOS/OOT/Deviations/Laboratory incidents

Role & responsibilities Oversee and manage the Quality Control department to ensure efficient laboratory operations. Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards. Supervise and mentor QC staff, providing training and technical support to maintain high performance. Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products. Ensure timely and accurate analytical testing, stability studies, and method validations. Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA). Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes. Review and approve analytical data, reports, and COAs (Certificates of Analysis). Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment. Manage laboratory documentation, ensuring compliance with data integrity guidelines. Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses. Stay updated on industry trends, regulatory changes, and advancements in analytical techniques. Preferred candidate profile Bachelor's/Masters degree in Pharmacy, Chemistry, Microbiology, or a related field. Minimum 12+ years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.). Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc. Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation.

Lead Quality Assurance operations, ensuring compliance with GxP and continuous improvement. Oversee Quality Systems to maintain compliance with regulatory requirements and procedures. Ensure timely execution of Quality Assurance activities, including Change Controls, CAPA, Deviations, OOS, OOT, and Market Complaints. Represent QA during regulatory/customer audits, track compliance plans, and implement corrective actions. Monitor the effectiveness of CAPA programs and ensure accurate implementation. Facilitate batch review and release per regulatory requirements. Investigate and resolve non-conformances, ensuring appropriate corrective and preventive actions. Ensure execution of Annual Product Reviews and escalate recommendations to senior management. Maintain adherence to safety, data integrity, and ethical conduct policies. Oversee in-process Quality Assurance (IPQA) for compliance with shop floor activities. Review and approve key documents across Production, Warehouse, Quality Control, Engineering, R&D, and EHS. Participate in cross-functional meetings, ensuring alignment on quality, compliance, and process improvements. Support sterility assurance programs, media fills, and aseptic process monitoring. Coordinate internal audits and ensure timely resolution of observations. Monitor and enhance aseptic practices in the manufacturing environment. Ensure timely investigation and resolution of customer and market complaints. Provide batch disposition decisions and approve release documentation. Ensure timely submission of required documents to regulatory and cross-functional teams. Prepare and review protocols, procedures, and QMS elements to sustain compliance. Identify training needs for QA team members and conduct required training programs. Lead quality discussions in periodic review meetings, supporting compliance and process improvements. Track and monitor timely closure of deviations, root cause investigations, and CAPA. Ensure timely resolution of queries from customers and third-party review teams. Promote continuous quality improvements through effective cross-functional collaboration. Promptly report and escalate non-conformances or critical quality issues for assessment.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: Alathur Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Company: Strides Pharma Department: IPQA Profile: - Executive Office Locations: KRSG Plant, Bangalore Qualification – B. Pharmacy/ M. Pharmacy Experience – 2 to 6 years (Must have exposure to OSD) Job Description: • To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. • QA overview for clean room behaviour and aseptic activity. • Review of batch processing records. • Review of all documents relating to the manufacturing, Packaging & analysis report prior to batch release. • Review of documents of respective areas and logbooks for adequacy and completeness. • QA overview for receipt of material from warehouse to production. • IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. • Review and Control of SOP’s, Specification, BPR issuance, Master Formulae and Records. • Preparation & Review of process validation protocols and reports. • Executing the validation/revalidation activity in the absence of authorized person. • Any job activity assigned by HOD • Responsible for regulatory audits with exposure equivalent to WHO Geneva PQ/USFDA Competencies: • Execute IPQA Excellence by setting clear benchmarks. • Smart Thinker and displays smart/ tactical moves & mental agility. • Is open and flexible when faced with changing circumstances and finds ways and means of doing things and not get struck with the past. • Comes up with ideas which are different and can be used commercially, profitably and growth. • Support and guide subordinates by giving appropriate examples & feedback. Encourage team to come up with new ideas. • Proposes solution which has elements of sustainability.

Preparing bills for Payment and performing the estimation of of quantities along with order. Analysis of rates of Non BOQ items. Excellent knowledge of BBS. Prepare & process Subcontractor bills. Reconciliation Statement. Planning Monitoring. Required Candidate profile Only those candidates should apply who have experience in building projects.

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients worldwide. Education: BE/BTech , BPharma , MSc, MPharna Experience: 4-7 years Key Skills: Shiping Validation, Change Control, CAPA, Deviations Primary Responsibilities To handle end to end shipping validation related to various products comes under cold chain scope for new products/routes/modes/new pack profile etc. To generate technical documents and risk assessments to leverage validated shipping routes to others. To write the shipping validation protocol, execution, and report preparation in collaboration with CFTs. To support introduction in active solutions as part of cost-effective and ESG initiatives. To ensure all QMS records such as CCF, CAPA, Events, CAPA effectiveness check etc. are timely initiated, reviewed and closed in coordination with internal external CFTs timely without any delays and extensions. To support operations team with respect DR (dispatch record) review and timely make it effective for hassle free execution of shipments. Timely investigate shipping related incidents and facilitate the batch release. To create the data base for shipping validation for various Lanes/routes/mode of shipment/Load pattern/Volume/Passive/active mode etc. Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities. To ensure mandatory and periodic training are completed Identify potential risks and develop strategies to mitigate them. To closely work with operations team in upkeeping facility and to ensure audit preparedness. To face regulatory, customer/consultants/Internal, statutory and safety audits as part of WH and logistics compliance. To provide timely response to all QA internal/external audit and implement CAPA holistically. To perform Internal audit at all WH locations and close the audit loop To ensure all digital projects are effectively implemented with CFT collaboration, automation, migration from manual process to electronic etc., Review of URS, Risk Assessment, Impact Assessment, Protocols, and Reports for the equipment and facility qualification. Establishing and review of EHS objectives, targets and management programs in the department. To support quality team regarding QMS review, PQRs, Trend report, facility review reports etc To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines. Adhere to the companys policies and ensure to align the warehouse activities to meet the companys business goals.

JOB RESPONSIBILITIES : [A] Regulatory Compliance : 1. To co-ordinate with corporate regulatory department for submission of documents as part of filing of DMF, updating and response to queries to US, Europe, China, Japan, Korea and Rest of World market. 2. To co-ordinate with various department for the timely submission of documents and its compliance. 3. Coordination with quality control, analytical development lab (ADL) and corporate validation Lab (CVL) for specification and standard test procedures. 4. Coordination with CQA for document preparation and implementation. 5. Keep the track of technology/Analytical Method transfer and other documents received from ADL and R&D. 6. Responsible for co-ordination during regulatory inspections and customer audits. Responsible for co-ordination with all stake holders for appropriate action plans for the corrective and preventive actions (CAPA) and timely closure. 7. Review and approval of stability summary report and handling of stability failures. Responsible for timely communication with corporate regulatory department on the stability failures for further actions with regulatory agencies and customers. 8. Responsible for the co-ordination with QC and other agencies for the timely qualification of working reference standards (WRS) of APIs, intermediates and impurities. 9. Responsible for the management of Skip Testing and associated documents. 10. Responsible for ensuring compliance of products against monograph specification. 11. Review and approval of analytical raw data before the regulatory submissions for filing. [B] Validation. 1. Responsible for review and approved of Process Performance Qualification protocols and reports through Documentum system. 2. Responsible for review and approved Cleaning Validation and Verification protocol and report through Documentum system. 3. Ensure compliance of validation master plan. A. Batch release and Dispatch: 1. Responsible for batch release, Certificate of analysis and material dispatch related activities. 2. Responsible to communicate the business development and PPIC in case of any delays in the dispatches due to any reasons. B. QMS: 1. Responsible for Handling of Market complaint, returned goods and Recall activities. C. Product review: 1. To ensure preparation, review & approval of Annual Product Quality Review (APQR) as per scheduled timelines in coordination with other departments. D. Audit and Compliance: 1. Responsible for audit preparation, compliance and response to regulatory and customer. 2. Responsible for Retain sample management of APIs & Saleable Intermediates. 3. Perform internal audits within Alembic site. E. Customer Support/ Compliance: 1. Co-ordinate with Production, QC, supply chain, logistic, purchase and Marketing department for dispatch related activities and customer queries. 2. To support the business development team during the development of new customers by providing required information as part of questionnaire assessment and Technical quality agreement. 3. Coordination with quality control for specification, standard test procedures and QC related queries generated by customers. 4. Handling of CAPA & Change control activities for implementation, monitoring and assessment. 5. Review and approval of documents in DCS/Documentum. 6. Any other task assigned by QA Head.

Role & responsibilities - QA 1. Personal Hygiene check-up of the staff and employees 2. Maintaining Quality Aspects and issuing Line clearance in Production department. 3. Controlling Document flow and completion of BMR and BPR in both the above areas 4. Checking Log books for the machineries in the above said areas 5. Issue and Receiving of Stereos/Computer generated OPD for packing 6. Ensuring In process controls as per Procedure. 7. Ensuring process is validated and carried out as per batch record instructions. 8. Ensuring process is validated and carried out as per batch record instructions. 9. Ensuring status labels/labeling of containers, equipments and materials. 10. Ensuring online documentation and timely entries of all operations/activities. 11. To monitor and ensure physical parameters such as Temperature, RH & Differential pressure. 12. Monitoring of personnel movement and clean room behaviour in process area. 13. Collection of stability and control samples 14. Collection of Finished product samples 15. Machine parameter verification 16. Verification of loads as per validated load pattern in Autoclave 17. Any other assignment given by the Quality assurance manager from time to time. For - QC 1. Total quality control of all type of formulations. 2. Sampling of Raw Material and Packing Material 3. Conduct Quality audits in consultation with Manager-QA 4. Analysis of Packing material, Raw material and Water analysis 5. Maintains records, prepare reports, and composes correspondence related to the work. 6. Preparation of volumetric solution, reagents, standard solution 7. Analysis of formulations manufactured in the facility 8. Preparation of CoAs and other documents 9. Evaluates and verifies junior employee performance through the review of completed work assignments and work techniques. 10. Calibration of equipments in the department. 11. Validation and calibration of equipments in Quality Control department. 12. Stability studies as per ICH guidelines. 13. Preparation of OOS 14. Preparation of deviation and change control. For - Production 1. To monitor all production activities of production department. 2. To plan department production schedules according to marketing requirement. 3. To co-ordinate with Plant Head and Stores-In-Charge for procurement of raw and packing materials required for production. 4. To approve all raw/packing material indents for batch manufacturing of products. 5. To plan monthly production schedules and make necessary changes in day to day schedules whenever required 6. Ensure optimal usage of manpower for carrying out different activities in the department. 7. To co-ordinate with maintenance department regarding the utilities requirement and its performance. 8. To co-ordinate with Q.C. department for approval of Raw Materials/Semi Finished/Finished products. 9. To co-ordinate with Q.A. in preparation of MMR's, BMR's/ BPRs and SOP's. 10. To co-ordinate with concerned agencies for validation of critical areas and equipment. 11. To co-ordinate with Q.A. for validation of equipment and preparation of SOPs. 12. To follow cGMP in all areas of production. 13. To co-ordinate with product development during processing of new products. 14. To ensure that all BMR's and other production documents are maintained as per requirement. 15. To maintain discipline in the production areas. 16. To ensure safety of workers and other staff in departments. 17. To ensure that manufacturing and other operations are carried out as per the laid down procedures in MMR's and SOP's. 18. To co-ordinate with maintenance department for general preventive maintenance and breakdown maintenance. 19. To appraise Plant Head /Management regarding day-to-day production activities. 20. To train and arrange training for personnel. 21. To ensure hygiene in all areas of production and hygiene of personnel in the department. 22. To delegate responsibilities to subordinates whenever required. 23. To ensure that proper batch yields are obtained. 24. To indent for consumables and miscellaneous items required for production. 25. To carry out any other duties assigned by Plant Head. 26. Responsible for the day - today production planning. 27. Work assignment to production executives as per production planning. 28. Monitoring the GMP documents like equipment logbooks/sheet, records of daily activity, housekeeping etc. 29. Online filling of BMR, BPR of the batches and review of the same. 30. Preparation of Monthly report, production planning and Implementation, Yield improvement, Optimum Capacity Utilization, Productivity Improvement, Reduction of Wastage. 31. Periodic audit of all the activities / operation of the plant ensure statutory compliance / In-house standard compliance. 32. Submitting consolidated monthly report on all aspects of Plant operations to the Administrative Director. Perks and benefits Commensurate with experience and performance track record-will not be a constraint for the right candidate.only Candidates with Pharma experience are requested to apply.

Role & responsibilities Production Planning: Doing Daily/Weekly & Monthly Planning of Production based on availability of PM, BM in the ERP. To share the firm plan with the procurement team for the current week and tentative plan of following week to order packing materials. Check whether the blends are approved before taking planning for Packing. Planning the Manpowers based on the production plan for the Month. Production & Packaging Execution: Responsible for achieving monthly Production Goals. Estimating the amount of material, equipment, and labor required for production. Promptly addressing and resolving production issues to minimize delays in production, Monitor the MSH level & do the changes in planning accordingly. Coordinating production operations in accordance with material, labor, and equipment availability. Coordinate with Blending depts. to see the availability of Blend & plan timely availability of PM/RM for production. Responsible for deciding Specification of the packaging material to prevent cross contamination and increase production efficiencies, Product safety during storage and handling. Monitoring trouble shooting of the problems faced during the normal operation of the packaging. Properly handling the shift end activities & records. Recommending viable solutions to reduce production costs as well as improve production processes and product quality. Promptly informing the relevant departments of any changes to current production schedules. Ensure proper CAPA is done for all the deviations identified. Co-ordinate with Sales, Marketing, and Purchase, Quality and finance team for different supply related issues and material connectivity. Daily coordinating with flavor making team for stock for masala blending operation. Production floor management Manpower, GMP,5S etc. ERP: Monitoring & Execution of all types of Production order in ERP. Push order of PM/BM to WMS for the next days production. Ensure all the production orders are ended in the ERP by EOD. Coordinate with IT team to clear all the pending errors in ERP to complete the order report finish. Check the blending material inventory and coordinate with BM team for the Blend. Inventory handling and data checking and monitoring in ERP and WMS. Documentation: Managing end-to-end documentation of daily production, scrap, rework & complaint register as well as tracking any complaints and ensuring resolution of the same. Standard Operating Procedure (SOP) for all packing machine, Check list for all equipments. Inventory Management: Plan inventory requirement (Demand vs. supply) for the effective functioning of the production department. Co-ordinate with Sales, Marketing, and Purchase, Quality and finance team for different supply related issues and material connectivity. Provide requirement to procurement team based on the stock and lead time of delivery. Storage & Dispatch Management Responsible for the Products to be ordered based on product movement and schedule Managing and auditing stock inventory. Maintain Stock Verification weekly and report to manager on a regular basis. Material Planning as per Indent & short fall of requirement weekly/monthly. Daily Stock Maintaining with Blended/Flavored Tea, Coffee & Packaging Material. Raw material handling With FIFO system. Hygiene maintain & safety maintain (Warehouse/ Factory), Physical stock taking in month end. Month end Inventory with variance posting in system as per physical stock, Billing. Training & Development: Identify training needs & schedule training to the subordinates and Workers in the department. Timely evaluation of the subordinates. Preferred candidate profile Graduate/ Diploma from an Engineering preferably (Mechanical Stream) Minimum - Exp. 10 years in FMCG / Foods / Nutraceuticals. Analytical skills with a sound understanding of techno commercial aspect with quantitative & conceptual abilities. Good Management and supervisory skills Worked before in ERP mandatory Decision making ability Result Orientation Problem Solving Skills Man Management Skills Proficiency in MS Office package Have to plan production activities, production meetings Experience of automated warehousing - Warehouse Management System (WMS) and ASRS (Automated Storage and Retreival System. Experience of powder handling plants Highly effective in utilizing resources, improving process, enhancing quality, reducing cost Extensive experience in Production Quality & Maintenance activities

1.Responsible for batch record issuance. 2 Responsible for issuance of change control 3.Resposible for implementation of ISO & Quality Management System 4. Responsible for calibration & validation of Equipements & Instruments 5. Responsible for inprocess Quality Checks 6.Resposible to implement CGMP 7. Responsible to monitor product activity 8. Responsible for issuance & retrival of control document 9. Resposible for dispatch verification 10. resposible to prepare process validation proyocal & record

Role & responsibilities Physical checking of RM/PM Material with verification documents & labelling. To check the material is Received from Approved Vendors. Arrangement of Materials at proper designated areas. To Prepare GRN in SAP for Received of incoming material. To intimate Q.C. Department for Material sampling and after that the materials to be shifted on approved or rejected area. Material requirement Received from Production Department & Issue as per that, also issued material weight verify as per issued requirement. To maintain Physical Stock of RM/PM. To maintain all log books. To maintain Cleaning Record & supervision of all dispensing location with logbooks To prepare stock valuation every month. Corresponding with Head office. Maintain narcotics, MA-I, RS-II stock & record. GRN for Received of RM/PM in SAP Co-ordinate with Production, Purchase, QA-QC and Other Department. To Raise Purchase Requisition as per Production planning and to ensure availability of material on time. Co-ordinate with cross functional teams & purchase as well with management for smooth operations Material receiving, warehousing, distribution and maintenance operations. Ensure that the store is kept clean and organized To maintain of SOP trainings, CAPA, Deviation and Change Control. To maintain standards of health, hygiene, safety and security. To maintain stock control and reconcile with SAP.

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Key Responsibilities: Review and verify quality-related documents and procedures. Handle change control, deviations, and impact assessments. Manage incidents, investigations, and CAPA implementation. Oversee market complaints, product recalls, and mock recalls. Prepare and review SOPs, validation protocols, and reports. Ensure compliance with batch manufacturing and packing records. Monitor shop floor activities for quality assurance. Implement and manage quality control processes. Perform other tasks as assigned by management. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma Industry : Pharmaceutical Formulation/API Experience: 06 - 11 Years Role: Sr.Officer/Executive Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

CANDIDATES HAVING EXPERIENCE IN EXTERNAL / TOPICAL PREPRATIONS (Ointment, Creams, Gels) WILL BE GIVEN PREFERENCE. Position Overview: As an Assistant Manager in the Quality Assurance department at Universal Twin Lab in Silvassa, you will play a pivotal role in ensuring compliance, quality, and operational excellence within the pharmaceutical manufacturing environment. Reporting directly to the Quality Assurance Manager, you will assist in leading a team responsible for validation, qualification, quality management systems (QMS), documentation, and overall compliance. Role & responsibilities Lead QA team in ensuring compliance and quality standards. Oversee QMS activities including change control, deviations, complaints, recalls, and CAPA. Assist in process validation for oral solid dosage forms. Coordinate equipment and utility qualification activities. Review and approve master documents and reports. Participate in audits and inspections. Monitor daily QA activities and prepare regular reports. Preferred candidate profile Required Qualification: - B.Pharma/M.Pharma (MALE Only) Industry : Pharmaceutical Formulation/API Experience: 10 - 15 Years Role: Assistant Manager QA Department: Quality Assurance Employment Type: Full Time, Permanent CTC: Will depend on Current CTC & Interview Performance.

Job Description Job Title: GCP Lead Employment Type: Full time Location: Bengaluru/India Experience: 5-8 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Canada, the United Kingdom, Italy, Poland, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities ¢ Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation, Internal Audits, External Audits, Risk management, Innovation and Continual improvement.. Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and implementing/ monitoring them for QA function, as applicable. Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform reviews/approvals. Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for quality and compliance in pharmacovigilance. Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records. Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans. Facilitating regular CAPA status and metric reports to ensure senior management awareness. Participating in governance/oversight activities including trend assessment or other quality review. Knowledge in the area of Clinical Operations is preferred. Required Skills and competencies: Quality Assurance Nonconformance management (CAPA, Deviations, Issues) GCP Stakeholder management Conflict Resolution Problem Solving

Work Location: Naidupet (Near TIrupati) Role & responsibilities 1. Handling of market complaints. 2. To acknowledge the complaints to the reporter 3. conducting complaint Investigations 4. Co-ordinate with functional investigators (Cross Functional Team/Subject Matter Experts) for timely completion of complaint investigations. 5. Follow up for complaints closure letter from the Reporter and close the complaint in complaints closure form. 6. Involve in root cause analysis, Failure Investigations and Risk assessment activities. 7. Initiate, review of Corrective action & preventive action and To prepare trend of complaints. To Maintain all the Quality management system documentations. Preferred candidate profile B. Pharma/Msc Educational qualification with 03 to 08 years experiance Perks and benefits Best In industry

Role & responsibilities Cross functional and within department co-ordination to ensure all the Change controls, Exceptions, Process non-conformance and Material non-conformance for the closure within due date. Responsible for all the change control coordination activities, Coordination with customers for approval of change controls in Quality management system module Monitor and to trace the Change controls, Exceptions, Process non-conformance and Material non-conformance in Quality management system Initiate, review the Corrective action & preventive action and to coordinate with other departments for its closure within due date. Prepare and review the trends for Change controls, Process non-conformance and Material non-conformance, Exceptions and Corrective action & preventive actions Preferred candidate profile 02 to 07 years pharma formulations experience preferrable. Perks and benefits As per Industrial standards

Qualification: Regular M.Sc. (1st class is mandatory) - 60% Throughout in All Streams Work Experience: 6– 12 Years (In the field of QA in Pharma/Chemicals/Agrochemicals)

-We are looking out candidates for different sections and positions in Quality Assurance department. Such as IPQA, QMS, Lab QA, AMV QA. Interested candidates can share their resumes on a.salunkhe@v-ensure.com & n32admin@v-ensure.com Role & responsibilities 1) IPQA - In process Checks. - Line clearance - Review of BMR, BPR 2) QMS - Handling and review of Change control, deviations, CAPA of different departments. - Document issuance, archival, retrieval. - Facing the Audits. 3) Lab QA & AMV QA - Managing Analytical QA activities. - Review of documents related to QC i.e. Raw material, finished products, stability. - Review of documents of Method validation, Assay. Preferred candidate profile - Candidates must have experience in Pharma formulation plant. - Must have good communication skills. - Candidates from Regulatory plant will be given preference. - Immediate joiners will be preferred. Perks and benefits Best in the industry

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across OSD and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)

• Responsible for analytical documents review, filing after approval for: • Batch Analysis • Method Validation and Method Transfers • OOS / OOT Investigations • Stability Protocols, Reports, Data • Certification of standards • Review of Specifications and Test Methods • Review of Calibration and Qualifications of Analytical Instruments • Audit trail review • Should understand all analytical instruments like HPLC, GC, Spectrophotometers, Other analytical instruments • Understanding of good laboratory practices in Quality control and Analytical Development and Validation • Understand 21CFR Part 11 requirements, Audit trail reviews, GMP requirements, ICH guidelines on Specifications, Method validations.

• Responsible for QA activities & review of documents in the area of: • Quality Management Systems, Incidents & Investigations, IPQA, Internal Audits • Document control • Batch review and release, Dispatch • Validations, Qualifications • Product Quality review • Logging, Investigating and closing Quality events (Deviations, OOS&OOTs, Complaints), Participate in Investigations • Logging, Tracking, Closing Changes, CAPAs • IPQA and Internal Audits • Document Management – Issuance, Retrieval, Archival • Review of Quality System documents such as -Batch records, Validation reports, Qualification reports, calibration reports • Review Dispatches and documentation • Review Vendor Qualification, • Coordinate Training Management, Samples dispatch • Sampling of intermediate/ APIs

Roles and Responsibilities Conduct vendor audits, root cause analysis, and deviation management to ensure compliance with quality standards. Prepare SOPs for QMS implementation and maintain accurate records of market complaints, CAPAs, and change controls. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Ensure timely completion of tasks related to APQR (Advanced Product Quality Review) and participate in continuous improvement initiatives. Maintain a high level of accuracy in data entry, documentation, and reporting.

Role & responsibilities 1. To maintain and ensure the cGMP compliance. 2. Preparation of MPCR, PVP, PVR, HSP & HSR based on TTD. 3. Preparation of proposed commercial MPCR based on marketing requirements. 4. Raw material tracking for the smooth functioning and timely execution of the products. 5. QMS related activities (CRF/Deviation/Investigation/CAPA) and compliance. 6. Follow up for CRF approval. 7. Creation of HALB code and preparation of BOM in SAP 8. Compilation of validation documents like Process validation report and Hold time study report. 9. Any other job assigned time to time by superiors. Preferred candidate profile US Market experience in ANDA filing, CMC documentation, regulatory compliance, and technology transfer. Perks and benefits As per company policy