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8.0 - 10.0 years
7 - 11 Lacs
Pune
Work from Office
Job Description To review/approval/closure, rejection/drop (if required) of Quality system documents such as Deviation, change control, CAPA, OOS, OOT, Re-process & Re-work, market complaint, market returns & LIR. To ensure & handle the investigation for Out of Specification Results, OOT, Deviations, Product failures and Market Complaints are adequately performed and documented with appropriate Quality Risk Assessment activity, Corrective and Preventive Actions based on the results of the investigations are identified and implemented. To preparation review & Approval of Quality system trend. To verify In-process Quality Assurance during production activity and sampling at different stages of processing/packing as per requirement. To review & approval of API Analytical Method Transfer Protocol/Report and method validation documents. Preparation & review of Annual Product Quality Review. Preparation, Review & Approval of Hold Time Study Protocol/Reports, and other study protocols/reports Work Experience 7-9 year Education Masters in Science or Pharmaceutical Chemistry Post Graduation in Pharmacy Competencies
Posted 4 days ago
2.0 - 7.0 years
1 - 5 Lacs
Chennai
Work from Office
Experienced in preparation,execution&review of process/cleaning validation,equipment qualification,calibration, preventive maintenance, and validation schedules. Ensures effective implementation validation master file. resume to hrd@stedmanpharma.com
Posted 4 days ago
10.0 - 12.0 years
10 - 12 Lacs
Hyderabad
Work from Office
Job Title : Assistant Manager Or Deputy Manager Job Location : Hyderabad Department : QA Reports to : HOD Job Objective : To perform the QA activities in view of system upgradation and improvement in the existing procedures. Job Role: 1. Execution & co-ordination for investigations, Identification of root cause along with assignment of adequate CAPAs for Returned material, Incidents, Deviation, OOS, OOT, complaints & other quality events. 2. Logging, Review & Closing of the change controls and CAPAs along with implementation of CAPA and its effectiveness verification as applicable. 3. Responsible as site representative during Regulatory Audits and customer inspections to co-ordinate with the Inspectors /Auditors. 4. Preparation & review of quality risk assessment reports of products & general systems 5. Conduct on the Job Training and cGMP trainings. 6. Implement documentation system to develop, maintain, distribute and control of all Quality Control, Quality Assurance, Production, Maintenance and Warehouse records. 7. Planning & execution of internal quality audits and perform vendor audits for the KSMs and packaging materials for vendor qualification. 8. Co-ordination with the customer for compliance and day to day issues. 9. Quality agreements review and preparation. Job Qualification: Masters in Chemistry (Any specialization) Job Experience: 10 to 12 years Desired attributes: Technical / Functional: Should have exhaustive knowledge on the drafting skills (E.g. Investigations, Responses & compliance). Should have sound command on the English with speaking and Writing. Sound knowledge of the production operations, QC analytical techniques & facility and maintenance functions. Behavioral: Team management, Leadership, Project management, Proactive, Time management and Critical thinker.
Posted 6 days ago
4.0 - 8.0 years
0 Lacs
surendranagar, gujarat
On-site
As a Sr. Executive / Assistant Manager Quality Assurance (QA) at SAVA Healthcare Limited, Surendranagar Plant, your primary responsibility is to ensure the implementation and maintenance of cGMP practices, quality systems, and compliance with regulatory requirements. You will oversee QA activities including documentation, validations, audits, and shop floor compliance to uphold product quality and regulatory adherence. Your key responsibilities will include ensuring compliance with cGMP, SOPs, and regulatory requirements on the manufacturing floor, reviewing and approving batch manufacturing records (BMRs) and batch packing records (BPRs), handling deviations, change controls, CAPA, and quality risk management activities, conducting self-inspections, and supporting external/internal audits. You will review and approve SOPs, protocols, and reports related to validation, qualification, and quality systems, monitor and support validation activities, oversee document control, ensure timely closure of audit observations and CAPA implementation, and coordinate with various departments to ensure overall GMP compliance. Additionally, you will participate in training programs and provide QA training to cross-functional teams. SAVA Healthcare Limited (SHL) is a diversified pharmaceutical company committed to delivering quality-driven pharmaceutical solutions globally. Established in 2003, SHL has a strong presence in International Business, Animal Healthcare, Herbal Products, and Contract Research & Manufacturing Services (CRAMS). The ideal candidate for this role should have a B.Pharm / M.Pharm / M.Sc. degree with 4 to 7 years of experience in QA in a regulated pharmaceutical formulation plant. You should possess a strong understanding of GMP guidelines, quality systems, validation practices, and regulatory audits. If you are passionate about maintaining high-quality standards, ensuring regulatory compliance, and contributing to the success of a leading pharmaceutical company, we encourage you to apply for this exciting opportunity at SAVA Healthcare Limited, Surendranagar Plant, Gujarat.,
Posted 6 days ago
9.0 - 13.0 years
0 Lacs
indore, madhya pradesh
On-site
Cyano Pharma Pvt Ltd is a leading pharmaceutical organization in INDORE (MP) focused on quality, compliance, and innovation. We are looking for a highly skilled professional with strong expertise in Quality Management Systems (QMS) and Validation & Qualifications to ensure compliance with international regulatory standards (WHO, USFDA, EMA, MHRA). Key Responsibilities: Quality Management System (QMS): - Implement, maintain, and continuously improve the site Quality Management System in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA). - Prepare, review, and update SOPs, quality manuals, and quality policies. - Manage change control, deviation, incident reporting, and risk management systems. - Coordinate and support internal, external, and third-party audits, ensuring timely CAPA implementation and closure. - Monitor and analyze quality metrics to drive continuous improvement initiatives. - Provide training and awareness programs for QMS procedures and GMP compliance across teams. - Act as a key contact for regulatory inspections and customer audits. Validation & Qualifications: - Prepare and execute qualification protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and systems. - Lead process validation, cleaning validation, and computer system validation as per regulatory requirements. - Develop and maintain the Validation Master Plan (VMP). - Ensure periodic requalification and revalidation activities are performed according to schedules. - Review and approve all validation-related documents, including protocols and reports. - Ensure all validation activities comply with cGMP, data integrity, and documentation requirements. - Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes. Qualifications & Experience: - M.Pharm with 9-10 years of experience in Quality Assurance within the pharmaceutical industry. - Strong hands-on experience in QMS implementation and validation/qualification activities. - In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA). - Strong communication, documentation, and audit-handling skills. - Proficiency in MS Office (Word, Excel, PowerPoint) and quality documentation systems. - Location: Indore Benefits: - Competitive salary and performance-based incentives. - Opportunity to work on global compliance and regulatory projects. - Exposure to international audits and career advancement opportunities.,
Posted 1 week ago
2.0 - 5.0 years
2 - 3 Lacs
Noida
Work from Office
Role & responsibilities Education: B. Pharma/M.Sc./B.Sc. Experience: Min. 2 years Work profile: Shop floor IPQC (Tablet, Syrup, cream etc.) Basic knowledge of QA activities (Quality management system) Preferred candidate profile Email CV- Shubhamupadhyay.sanat@schwabeindia.com Phone -9628926944
Posted 1 week ago
15.0 - 19.0 years
0 Lacs
hyderabad, telangana
On-site
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,
Posted 1 week ago
5.0 - 9.0 years
0 Lacs
maharashtra
On-site
We are seeking a skilled QA Executive / Officer to join our Quality Assurance team. The ideal candidate will have hands-on experience in SOP preparation, internal audits, validation, cleaning validation, and quality systems (QMS). Key Responsibilities: - SOP Preparation, Revision & Training: Conduct gap analysis against QA SOPs, prepare and revise SOPs using Control Document Management System (CDMS), and conduct classroom training sessions for approved SOPs. - Audit & Inspection Readiness: Prepare annual internal audit schedules, conduct internal audits, and prepare audit reports. Raise CAPAs in TrackWise and verify effectiveness post-implementation. - Periodic Product Review (PPR): Prepare PPR for assigned products as per regulatory expectations. - Product Transfer & Validation Support: Support contract manufacturing sites during product transfers and validations. - Qualification Activities: Perform change control assessments from a validation perspective, prepare and maintain Site Validation Master Plan (SVMP), present monthly validation reports to the steering committee, and track and manage re-qualification schedules. - Cleaning Validation: Prepare protocols and reports for cleaning validation, conduct Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) studies. - Quality Management Systems (QMS): Conduct gap analysis against QMS standards, handle and document change controls, deviations, and CAPAs, and perform risk assessments for process changes or new product introductions. Interview Details: Walk-in Interviews: Monday to Friday, 2:00 PM 4:00 PM. Please carry your updated resume and passport-size photograph. Interview Address: Unit G-14, 15, 16, 17, PRABHADEVI INDUSTRIAL ESTATE, 408, Swatantryaveer Savarkar Rd, Prabhadevi, Mumbai, Maharashtra 400025. Job Type: Full-time Experience: Relevant - 5 years (Required) Expected Start Date: 01/08/2025,
Posted 1 week ago
5.0 - 10.0 years
0 Lacs
maharashtra
On-site
As a General Manager of Quality Assurance with 5-10 years of experience, your responsibilities will include validations and qualifications, preparation and implementation of the VMP & CMP, process validations, cleaning validation, and facility validation. You will also be in charge of equipment and instrument qualifications including URS, DQ, IQ, OQ, and PQ. Handling of deviations/incidences, internal quality audits, GMP audit system, annual product review, vendor audits, and qualifications are crucial aspects of this role. Your duties will also involve documentation, effective implementation of the document control system, preparation of Standard Operating Procedures (SOP), GMP & GLP records, and approval of Master Formula Records and batch manufacturing records. Quality control and stability studies will be under your supervision, and you should be fully conversant with the latest GLP requirements. Experience in handling sophisticated instruments like HPLC, GC, FTIR independently is required. Moreover, familiarity with ANDA and EU submissions, handling of regulatory deficiencies/queries work, preparation of Drug Master Files & dossiers for export markets are important responsibilities. Your expertise in ensuring compliance with quality standards and regulations will be essential in this role. If you are a detail-oriented professional with a solid background in quality assurance and a proven track record of successfully managing quality control processes and regulatory submissions, we encourage you to apply for this position.,
Posted 1 week ago
0.0 - 3.0 years
0 - 3 Lacs
Gandhinagar
Work from Office
About: Sahajanand Medical Division Medical division is approved by state and central licensing authorities and it delivers efficient performance to meet specific requirements. The SLTL brand stents embody that bold spirit, offering a unique blend of our leading-edge technologies and time-tested engineering With Technical Collaboration & Patent Design, the company started indigenous manufacturing of Coronary products, in 2009. The company has a dedicated in-house R&D department approved by DSIR (Department of Scientific and Industrial Research). We believe that every product we make should stand for something. Something more than expected. And thats why we dont manufacture products for stereotypes. We build them for you. Kindly go through our websites mentioned below for further details. Website: www.sltlmedical.com Roles & Responsibility: Handling QA - QMS activities Change Control Deviation Non-conformity documents Line clearance activities Document Issuance Work as an Internal Auditor Skill/Knowledge Required: Graduate / Post Graduate in Science, Pharma, Biomedical 0 to 3 Years work experience in Quality Assurance role. Preferred from Medical Device industry / Pharma Industry Preferred Local Candidate. Interested one can share resume on placement@sltl.com / Whatsapp - 7490055612
Posted 1 week ago
4.0 - 10.0 years
0 Lacs
hyderabad, telangana
On-site
You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,
Posted 2 weeks ago
4.0 - 7.0 years
2 - 6 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.
Posted 2 weeks ago
2.0 - 4.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules. 2. Responsible for preparation of facility, equipment, area qualification protocols and reports. 3. Responsible for execution of facility, equipment and area qualification activities. 4. Responsible for operation and handling of Dataloggers, HVAC related equipments. 5. Responsible for compilation and review of validation raw data and test certificates. 6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports. 7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments. 8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records. 9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities. 10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation. 11. Responsible for preparation of Utilities Annual summary reports.
Posted 2 weeks ago
3.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Responsible for review of specifications, STPs, GTPs and analytical test data sheets. 2. Review of analytical reports of raw material, packing materials, water samples, product samples, OOT, water trends and ensuring compliance. 3. Responsible to attend the training programs. 4. Responsible for monitoring of quality control Lab (Daily calibration, PMP, Instruments back up data, Excel work sheets lock, user log books). 6. Responsible for handling technology transfer documents. 7. Responsible for review of stability protocols, stability analytical data and summary reports. 8. Responsible for handling of change controls, OOS, OOT, Incidents and investigations. 9. Responsible for compliance of GLP in Lab. 10. Responsible for review and approval of LIMS related activities. 11. Approval and issuance of configured COA in LIMS. 12. Responsible for audit trail verification for QC lab instruments.
Posted 2 weeks ago
3.0 - 6.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
Responsible for production activities 1. Monitoring of area drains cleaning and documents updation. Updation of room / equipment status labels. Verification of material required for production activities. Preparation of area, equipments before batch activities. Execution of production activities. Monitoring of batch parameters. Updation of batch parameters. Samples handling (Sampling and labelling). Intimation of incidents to Shift in-charge. Assisting in column packing, unpacking and evaluation activity. 2. Chromatography column and resin monitoring. 3. Handling of documents Checking practical feasibility of new / revised SOPs, protocols. Updation of log books. Updation of BMRs and attaching annexures online. 4. Responsible for operation of following production equipments (but not limited to): AKTA Process Purification system Conductivity meter AKTA Pilot Purification system Peristaltic pumps TFF System Mixing Systems LAFU Filter integrity tester pH meter Heat exchanger Walk in cold room Freezer room 5. Training: Attending training on SOP's / GMP as per schedule. 6. Responsible for Quality Management Systems Initiation of breakdown request. Initiation of CRN's. Initiation of incidents, Investigations and CAPA.Please enter job description
Posted 2 weeks ago
2.0 - 5.0 years
1 - 4 Lacs
Hyderabad, Jadcherla
Work from Office
1. Following GMP, safety practices in production facilities and work place. 2. Responsible for production activities: Monitoring of area drains cleaning and documents updation. Updation of area / equipment status labels. Samples handling (Sampling and labelling). Arrangement of material required for activities. Assisting in Execution of production activities. Updation of BMR's. Receiving material (RM miscellaneous). Returning miscellaneous materials to warehouse. Planning and Execution of FDS thawing and dispensing activities. Assisting in product changeover activities before batch execution. Assisting column packing and execution of equipment specific protocols. Assisting in Equipment (Purification TFF system) cleaning.
Posted 2 weeks ago
2.0 - 6.0 years
1 - 4 Lacs
Kozhikode
Work from Office
Responsibilities: * Ensure compliance with GMP, GLP & BPR review. * Conduct process validation, cleaning verification & change control. * Collaborate on batch manufacturing & release processes. * Prepare SOPs, BMRs & BPRs.
Posted 2 weeks ago
15.0 - 20.0 years
12 - 14 Lacs
Ankleshwar, Gujrat, India
On-site
Job Title: Quality Control Head Industry: API / Pharma Manufacturing Job Location: Ankleshwar, Gujarat Experience Required: 15 to 20 years of relevant experience in Quality Control within the API pharma industry Salary: 12.0 LPA to ?15.0 LPA Education: M.Sc. / B.Sc. (Chemistry) or M.Pharm / B.Pharm or equivalent Key Skills Required: Strong knowledge of data integrity principles Hands-on experience with instruments like HPLC, GC, and UV Experience in cleaning validation and microbiological testing Familiarity with incident investigations and regulatory compliance About the Company: A leading API pharma manufacturing group known for its strong global presence and commitment to quality and innovation. Job Responsibilities: Lead and manage the Quality Control (QC) department to ensure quality at every stage of manufacturing and testing. Oversee sampling, inspection, and testing of raw materials, packaging materials, in-process, and finished products. Ensure timely release or rejection of batches based on quality data. Handle stability chamber management, testing, and shelf-life evaluations as per protocol. Conduct microbiological analysis for raw materials, finished goods, water, and environmental monitoring. Review trends in physicochemical and microbiological test data for compliance. Manage out-of-specification (OOS), deviation investigations, and analytical support for product recalls and complaints. Coordinate with QA and R&D on specifications, analytical procedures, and validations. Ensure equipment/instrument qualification, calibration, and preventive maintenance. Maintain and audit QC records, reference/working standards, and ensure data integrity systems are in place. Supervise glassware cleaning, protocol validation, and implementation of cleaning procedures. Plan and execute internal audits and ensure compliance with GLP and GMP standards. Review and validate SOPs, protocols, and test methods (pharmacopeial & in-house). Support employee training in alignment with cGLP and cGMP practices. Evaluate change control proposals, failure investigations, market complaints, and implement improvements in QC systems. Ensure all activities follow company reporting systems and regulatory expectations.
Posted 2 weeks ago
5.0 - 8.0 years
10 - 14 Lacs
Mumbai
Work from Office
Job Title:- KMIL- Wholesale Banking- Risk Monitoring Analyst Grade:- M4/M5 Location:- Mumbai Track financial and project performance covenant: Monitoring financial and project performance against predefined convenants. Identify deviations and promptly communicate findings to relevant stakeholders. Project performance analysis: Conduct through analysis of project performance metrics. Provide insights and recommendations to mitigate risks. Track Compliances to sanctions conditions: Moniotor compliance with sanctions conditions imposed on credit facilities. Take proactive measures to address any non- compliance issue Site Visit: Conduct on site visit to assess the progress and status of projects. Documents observations and report findings to management Compliance with RERA regulations: Ensure adherence to regulatory guidelines and internal policies. Stay updated on regulatory changes and implement necessary adjustments. Early warning signal tracking: Identify early warning signal as per the existing policy indicating potential credit risks. Collaborate with relevant teams to develop strategies for risk mitigation. Coordination with business and credit underwriting team Liaise with business units and credit underwriting teams to gather relevant data and insights. Collaborate on credit risk assessment and monitoring activities. Job Requirement- MBA with 5 to 8 Years of experience is preferred
Posted 2 weeks ago
4.0 - 9.0 years
1 - 4 Lacs
Vasai
Work from Office
1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. Required Candidate profile 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory 6. MARKET COMPLAINTS and CAPA.
Posted 2 weeks ago
15.0 - 18.0 years
15 - 17 Lacs
Navsari
Work from Office
Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Market Complaints, product recalls and Returned goods. Responsible for review and approval of new as well as revised related Specification, Standard Test Procedure and Analytical Work Record. Responsible to design validation/ qualification strategies Responsible for validation /qualification of processing equipments, cleaning equipments and testing equipments on time. Responsible for day-to-day validation planning and execution activity. Responsible to approve specifications, standard test procedures and analytical work records. To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports. Responsible for regulatory & customer audits preparation, execution and its compliance. To approve and authorize technical agreements from customer and outside party. Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department. Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing. To ensure the implementation of quality risk management procedures. Responsible to finalize training topics as per requirement and organize annual training plan with Training coordinator on cGMP and technical aspects. To ensure that processes needed for the Quality Management System are established, implemented and maintained. Responsible for investigation & review of non-conforming events including customer complaints and internal non-conforming events. Responsible for report, review, evaluation and tracking of change control, deviation, incident, market complaint, non-conformance report, product recall, corrective and preventive action. Responsible to ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of Quality Management System. Responsible to perform vendor audits and internal audits. To check audit trial and back-up verification documents. Participation in study raised through Quality Management System.
Posted 2 weeks ago
1.0 - 4.0 years
1 - 3 Lacs
Bengaluru
Work from Office
Job description Summary of Key Responsibilities Responsibilities and essential job functions include but are not limited to the following: Shift Handling Taking care of opening, mid, and closing shifts. Managing opening and closing of the caf. Team Handling Handling a team of 5-6 members. Training the team members. Cafe Management Handling the inventory of the caf. Cash handling. Maintaining the checklist of the cafe as per company guidelines. Customer interaction and order taking. Desired Candidate profile Required Knowledge, skills and abilities Communication Skills a. Candidate is able to talk fluently in Hindi & English b. Good listener 2. Flexibility a. Open for transfers b. Open for any shift timings c. Open for cleaning, utensils, and brooming cafe. 3. Experience with the QSR industry/F&B industry a. Has handled shifts independently. b. Inventory management 4. Customer Handling a. Handling customer queries and resolving them. b. Promoting a positive and healthy environment to customers. Perks and Benefits Chaayos provides you with the following: 1. Aggressive growth plan 2. Appreciation and incentives 3. Discounted employee meals 4. Child Shagun Policy 5. ESIC/ Term Life Insurance Policy 6. Eligible for Employee Provident Fund
Posted 2 weeks ago
1.0 - 4.0 years
1 - 4 Lacs
Chennai
Work from Office
Job description Summary of Key Responsibilities Responsibilities and essential job functions include but are not limited to the following: Shift Handling Taking care of opening, mid, and closing shifts. Managing opening and closing of the caf. Team Handling Handling a team of 5-6 members. Training the team members. Cafe Management Handling the inventory of the caf. Cash handling. Maintaining the checklist of the cafe as per company guidelines. Customer interaction and order taking. Desired Candidate Profile Required Knowledge, Skills, and Abilities Communication Skills a. Candidate is able to talk fluently in Hindi & English b. Good listener 2. Flexibility a. Open for transfers b. Open for any shift timings c. Open for cleaning, utensils, and brooming cafe. 3. Experience with the QSR industry/F&B industry a. Has handled shifts independently. b. Inventory management 4. Customer Handling a. Handling customer queries and resolving them. b. Promoting a positive and healthy environment to customers. Perks and Benefits Chaayos provides you with the following: 1. Aggressive growth plan 2. Appreciation and incentives 3. Discounted employee meals 4. Child Shagun Policy 5. ESIC/ Term Life Insurance Policy 6. Eligible for Employee Provident Fund
Posted 2 weeks ago
4.0 - 7.0 years
4 - 7 Lacs
Kolkata
Work from Office
JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.
Posted 2 weeks ago
0.0 - 4.0 years
1 - 4 Lacs
Hyderabad, Chennai, Bengaluru
Work from Office
Job description Summary of Key Responsibilities Responsibilities and essential job functions include but are not limited to the following: Shift Handling Taking care of opening, mid, and closing shifts. Managing opening and closing of the caf. Team Handling Handling a team of 5-6 members. Training the team members. Cafe Management Handling the inventory of the caf. Cash handling. Maintaining the checklist of the cafe as per company guidelines. Customer interaction and order taking. Desired Candidate Profile Required Knowledge, Skills, and Abilities Communication Skills a. Candidate is able to talk fluently in Hindi & English b. Good listener 2. Flexibility a. Open for transfers b. Open for any shift timings c. Open for cleaning, utensils, and brooming cafe. 3. Experience with the QSR industry/F&B industry a. Has handled shifts independently. b. Inventory management 4. Customer Handling a. Handling customer queries and resolving them. b. Promoting a positive and healthy environment to customers. Perks and Benefits Chaayos provides you with the following: 1. Aggressive growth plan 2. Appreciation and incentives 3. Discounted employee meals 4. Child Shagun Policy 5. ESIC/ Term Life Insurance Policy 6. Eligible for Employee Provident Fund
Posted 2 weeks ago
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