159 Deviation Jobs

As an Analyst, you will be required to possess knowledge of various analytical instruments such as HPLC, UV, FTIR, GC, Polarimeter, KF, Auto titrator, and more. You will be responsible for the QCC-QMS Section, overseeing test procedures, handling OOS, OOAL, Deviation, Change Control Note, Incident, and preparing Investigation Reports. Additionally, you will review instrument logbooks, raw data of materials, in-process, finished products, and water analysis. Your skills and proficiency should include expertise in Analytical Instrumentation Handling, Good Laboratory Practices (GLP) & Documentation Accuracy, Data Integrity & Documentation, Regulatory Compliance, SOP Preparation & Revision, Interpretation of Resulting Data from Analytical Instruments, Quality Control & Compliance, LIMS Operation & Data Management. You should also have a basic understanding of QMS Documentation (OOS, OOT, Deviation & Incident) and CAPA, Deviation, and Change Control Management. To qualify for this position, you should have a minimum of 1 to 4 years of relevant experience in the QCC Department. Candidates applying for internal job postings must have completed at least 2 years in their current job role.,

The ideal candidate for this role should have 6-10 years of experience and possess the following competencies: - Punctual with a proven track record of dedication and reliability. - A team player who is equally capable of working alone. - Fluent in both written and spoken English. - Knowledge and experience in peptides Quality. - Reviewing the Batch Manufacturing Records. - Executing and Monitoring Process Performance Qualification (PPQ). - Preparing Cleaning Validation Protocol and Monitoring Cleaning Validation/Verification activities. - Reviewing the SOPs, Validation, and Qualification Record. - Handling Dispatch and Line clearance activities. - Preparing Annual Product Review. - Initiating various QMS elements like change control, deviation, CAPA, etc. - Investigating Customer complaints, Return Goods, Recall. - Reviewing Reprocessing and Reworking. The key stakeholders for this position include the QA Team and other departments in the plant. The reporting structure for this role is to the QA Head.,

Must have minimum 4 years experience in QMS activity Issuance and management of QMS Forms (e.g., CC, CAPA, Deviation, etc.) Participate in the evaluation and investigation of quality-related issues Coordinate with cross-functional teams (CFT) and relevant stakeholders for issue resolution Review and compile supporting documents for QMS processes Maintain and update QMS log registers Ensure proper documentation and records management of QMS activities Perform artwork review to ensure compliance with quality standards Job Location: Kadi, Gujarat ( Bus facilities are available) Note: Immediate joiners will be preferred first

He should know computer good computer knowledge He should know and having expertise in Good Manufacturing Practices (Developing, implementing. Required Candidate profile And maintaining quality systems and procedures ( Deviation/OOS investigation , batch card /SOP drafting ) that align with regulatory requirements.

Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 02.08.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D Candidates also eligible Position : Executive / Senior Executive Qualification : M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 02.08.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786

As a valuable member of our team in the pharmaceutical industry, you will be responsible for various key tasks including CAPA, OOS, Deviation management, SOP's generation, and ensuring Validation, GDP, GMP compliance. Your role will play a crucial part in maintaining high quality standards and regulatory requirements. This is a full-time position with a day shift schedule. The ideal candidate should have a total work experience of 1 year, preferably within the pharmaceutical sector. The work location for this role will be in person, providing you with the opportunity to actively engage with the team and processes.,

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancements to achieve the desired levels of quality. You will lead and oversee the quality teams across all manufacturing facilities, focusing on continuous improvement initiatives. Team building will be a key aspect of your role, where you will be involved in establishing, inspiring, training, mentoring, and managing a team of QA professionals to adapt to new processes and tools effectively. Collaboration with business units to set quality targets for new and existing products, managing quality projects resulting from site consolidations or acquisitions, and working with the Quality Management System group to streamline and harmonize quality systems will also be part of your responsibilities. You will be responsible for maintaining the effectiveness of the Quality System across all Shalina manufacturing sites and Contract Manufacturing site, as well as implementing and monitoring an effective Vendor/Supplier development process. You will lead recruitment activities, ensure the professional development of direct reports and the overall company quality organization, and establish standards and metrics to support exponential growth while adhering to quality standards and regulatory guidelines. Additionally, your role will involve participating in various functional meetings, such as Supply Chain, Operational Excellence, and Sourcing, R&D. Your essential qualifications and experience include a degree in M.Pharm/B.Pharm/Master's in science, along with 15+ years of leadership experience in quality assurance, preferably in the pharmaceutical or life sciences industry. You should possess a strong understanding of ROW regulatory landscapes and international quality standards, exceptional commercial acumen, strategic business insight, and excellent consulting and communication skills to influence senior stakeholders effectively. Moreover, you should demonstrate personal credibility, strong interpersonal skills, integrity, dependability, and a results-oriented approach. Experience in working cross-culturally and cross-functionally with diverse colleagues is essential for this role. Your responsibilities will also include providing training efforts at Shalina sites as needed, advising and supporting alliance partners/service providers/central distribution center to ensure compliance with quality requirements, and offering immediate support during audits and compliance checks. In summary, as the Head of Corporate Quality, you will lead the development and execution of quality assurance strategies aligned with the company's goals, ensuring regulatory compliance, continuous improvement, and effective quality management systems across manufacturing facilities. Your role will involve team building, collaboration with business units, and maintaining compliance with global quality standards while supporting growth and customer satisfaction.,

13-15 years of experience with QMS Activity and all QA activities. Process validation cleaning validation Monitoring of IPQA Data Integrity

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

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.

Responsible for leading production operations, coordinating production staff and equipment, ensuring product quality and profitability, and overseeing and managing the production operations involved in injectable products.

Position: Officer/Sr. Officer Department: Quality Control-Chemical Qualification: B.Sc/M.Sc (Chemistry) Experience Required: 4 to 7 years in Pharma Industry (Sterile Plant) (Injectables) Location : Vadodara Job Description: Preparation of SOP, Specification, STP, ARDS, Protocol, Reports, Stability summary report, Miscellaneous document and analytical method validation inline of applicable pharmacopoeia and ICH guideline. To Initiate the QMS element as per requirement. Handling of QMS related activity i.e OOS, OOT, Deviation, OOC, Change control and CAPA. Review laboratories equipment calibration and their preventive maintenance, working standards etc. Review and Implementation of Pharmacopeial updation. Routine review activity related to QC department. To perform gap assessment of approved documents vs practices, facility, design, GMP requirements.

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,

Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material

Role & responsibilities Handled Microbiology QMS Activities. Should have experience in OOS,OOT protocol review Preferred candidate profile Male Candidate Preferred

Role & responsibilities Should Have Experience in Handling QMS in Quality Control Department. Handled OOS , OOT, Deviation, CC, Protocol Preparation Preferred candidate profile Male Candidates Preferred

Role & responsibilities IPQA:- Responsible for line clearance and in process checks of Production. Responsible for Sampling of in-process, Finished Product, control samples, stability samples, and Process Validation samples as per procedure. To ensure online rejection activities and environment monitoring in manufacturing and packaging areas. To conduct periodical log review. To review of batch documents (Batch Manufacturing, Batch Packaging records, and Quality Control analysis data of the batch). To ensure online documentation during manufacturing and packaging area. To prepare and review of Quality Assurance Standard Operating Procedures. To ensure Re-processing and Re-packing activity. Responsible to perform Acceptance Quality Limit and Pre Dispatch Inspection of finished product. Responsible for preparation of Annual Product Quality Review. Responsible to maintain the document as per current Good Manufacturing Practices. Responsible to initiate Change control\Deviation\Incident\Market complaint\non-conformance investigation. To assist the Head of Department for preparation of regulatory inspection. Any other responsibility assigned by Head of Department. Quality Management System:- 1. To coordinate with cross functional department for execution of training planners and maintain training record for same. 2. To master, issue and retrieve of SOPs/BMR/BPR/QC dockets and other documents in-line with the laid down procedure. 3. To maintain vendor related documents and conduct vendor audits. 4. To investigate and prepare Market Complaint investigation report. 5. To take follow up and communicate with customer/vendor regarding Complaint. 6. To handle Change control/Deviations/Incidents/NCR/CAPA. 7. Review of quality technical agreements.

Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc., To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements. To conduct/participate internal quality audits & regulatory / customer audits. Communications with External Vendors/customers for relevant information/documents Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities. Review of development and commercial batch documents

Job Title: Quality Engineer. Experience: 4 to 10 years Location: Mysuru Notice Period: immediate to 15 days Mandatory Skill: QMS, Capa, GMP/Gdp/ GLP, Change Control, Deviation, Sop Preparation JD : Good understanding of Pharmaceutical GMP/GLP/GDP practices. *Experience in Pharma QMS activities like, handling Change Controls, Deviations, vendor qualifications and SOP updates. *Understanding of Internal Audits and CAPA closures. *Supporting for Quality metrics program. *Proficient experience with MS-office is required. *Strong written and verbal communication skills are essential *Experience working with virtual teams • Understanding of ISO 9001:2015 is required. *Strong communication, teamwork, data analysis, inductive reasoning and root cause analysis skills are required.

Role Overview Responsible for qualification & calibration of Microbiology instruments and equipment as per procedures with QMS. Illustrative Responsibilities Ensure that qualification & calibration activities are planned and executed within time frame defined by the procedure and equipments are released on time as per the pre-defined schedule. Responsible for coordinating with lab supervisors / system owners for handling of any non-conformances or escalations Handling of QMS related activities like, Change control, CAPA and Deviation with its effectiveness check. Responsible for quality compliance activities for laboratory instruments qualification and calibration. Summarize, review, and report the analytical Instruments qualification and calibration for further approval. Ensure a disciplined work environment to provide expertise to subordinates colleagues in the proper performance of laboratory procedures. Ensure on time GDP in technical function with right first time (RFT) approach. Responsible for ensuring team compliance to EHS, Quality & Business policies Any other work given by management from time to time. Quality & Compliance Responsible for following GMP/GLP/ GDP/EHS policies by self as well as the team Required skills Technical expertise in Microbiology instruments qualification, calibration, protocol preparation and QMS. Build cohesive team valuing team spirit Able to handle biosafety cabinet, LAF, glass bead sterilizer, water bath, Autoclave, refrigerator, Incubator, Balance & pH meter etc. Clear thoughts and effective and crisp communication. Job requirement M.Sc – specializing in Microbiology/Biotech with proven experience of min. 2-3 yrs. in Instrument qualification and calibration. Awareness of analytical instruments qualification and calibration, protocol preparation, CAPA, Investigations, Deviations (QMS) Good Knowledge of ICH guidelines and different global regulatory authorities. Job Location - Mulund

Role & responsibilities BMR/BCR preparation and approval SOP preparation and approval Change control and Deviation handling OOS/OOT investigation & CAPA implementation Trackwise software and good Computer skill.

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Looking for professionals with strong stakeholder management and communication skills, experienced in Application Periodic Review, CAPA, Deviation Management, Supplier Assessments, and direct customer interaction in regulated environments.

As a QA Executive, you will be responsible for various quality assurance tasks including Change Control, Deviation, Out of Specification, Market Complaint, Corrective and Preventive Action (CAPA), and Annual Product Quality Review. Additionally, you will be involved in Audit Compliance Report Preparation, Label compliance, Legal Metrology (Packaged Commodities), FSSAIs Labelling and Display Regulations, and implementation of GMP/GHP requirements in the food industry. You will be required to manage Calibration activities both internally and externally, Equipment Qualification & Documentation control, Process Validation Protocol & Report Preparation, and Cleaning Validation Protocol & Report Preparation. Monitoring and compliance of Self-Inspection and Quality Audits, Technology Transfer activities, HACCP preparation and monitoring, QMS activities, Food safety-related activities, and training execution will also be part of your responsibilities. Furthermore, you will oversee the checking of Building and Facility, Equipment, HVAC System, and Process Validation. Managing GMP and Quality Documents, including CQPs & SOP's, Protocol and Reports, Formats, Logs and Log Books, and Batch Record will also be part of your duties. In this role, you will also monitor and review Reprocess and Recovery in manufacturing areas, ensure GMP Compliance in the plant on a daily basis, and coordinate with various stakeholders to maintain quality standards. This is a full-time position with benefits such as health insurance. The work schedule is during the day shift. The ideal candidate should have at least 2 years of experience in QA/QC, Quality assurance, Quality management, CGMP, Food safety, Food industry, and HACCP. Please note that the work location for this position is in person.,

You are invited to a Walk-In Interview at Zydus Corporate Park in Ahmedabad on Saturday, 28th June 2025, from 10:00 AM to 03:30 PM. Zydus is a global healthcare provider focused on innovation and committed to enhancing healthcare therapies to create healthier communities worldwide. ### SAP S/4 HANA Opportunities: 1. **SAP FICO Consultant:** - **Experience:** Minimum 5 years in SAP FI, FM, PS, CO, and S/4HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Responsible for designing and implementing SAP FI/FM solutions, integrating with MM, SD, and PPQM modules, and driving process improvements. 2. **SAP ABAP Developer:** - **Experience:** Minimum 5 years in OOABAP, SmartForms, IDocs, and SAP HANA. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Design, develop, and optimize ABAP programs supporting SAP applications. 3. **SAP MM/WM Consultant:** - **Experience:** 5 - 8 years with S/4HANA, knowledge of warehouse management is advantageous. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Drive SAP MM implementations and integrations with SD, PP, QM, WM, and FI modules. 4. **SAP BW Consultant:** - **Experience:** 5 years. - **Education:** BE/BTech/MCA in IT/Computer/Graduate & SAP Certification is an added advantage. - **Location:** Ahmedabad. - **Profile:** Expertise in SAP BW and BO, strong development and maintenance skills, knowledge about SAP Process, and excellent communication skills. ### Microsoft Technology Opportunities: 1. **Full Stack Developer (Dotnet + Angular):** - **Experience:** 5-7 years with Azure DevOps, AKS, and Microsoft SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop scalable solutions using .NET Core, Angular, and MS SQL. 2. **Dotnet Developer / ASP.NET Developer:** - **Experience:** 5-8 years with .NET Framework, IIS, WCF, and MS SQL Server. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop robust solutions using ASP.NET WebForms, MVC, and Core technologies. 3. **Sharepoint Developer:** - **Experience:** 6-12 years with Office 365, remote event receivers, and SharePoint migrations (2010-2016). - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Design and develop solutions using SharePoint Online, SPFx, React, PowerApps, and Power Automate. ### Infrastructure & Compliance: 1. **IT CSV (Computer System Validation):** - **Experience:** 3-5 years. - **Education:** BE/BTech/MCA in IT/Computer. - **Location:** Ahmedabad. - **Profile:** Role involves 24x7 user access management, maintaining Privilege and User Access Matrices, handling IT QMS activities, supporting software assessments, network maintenance, conducting risk-based failure tests, and representing IT processes during audits and regulatory inspections. This walk-in interview is for experienced professionals. Freshers are encouraged to apply online for future opportunities. Priority will be given to candidates who can join immediately and are willing to relocate to the job location. For more information about Zydus, visit [Zydus Website](https://www.zyduslife.com/zyduslife/).,