239 Deviation Jobs - Page 3

Role & responsibilities CSV validation, ensuring compliance with industry standards and regulations. Documentation of URS, validation plans, protocols, reports and risk assessments. Having sound knowledge in Gxp (GMP,GDP,GLP). Preparation and review of Gap assessment protocols. Preparation and review of IQ,OQ,PQ protocols & test scripts and documented the results. Preparation and review of Functional Risk Assessments (FRA). Preparation and review of Requirement traceability matrix (RTM) & Validation summary report Preferred candidate profile Bsc/Msc in chemistry with 3 to 5 years of experience in Computer System Validation in the Quality control department (API Industry ) only male candidates can attend interview .

Ipca Laboratories Ltd, Wardha is as API plant we are looking for Production Manager with below mentioned JD To ensure weekly / monthly production schedules as per plans. Monitor shift wise production and provide feedback to HOD on daily basis. To ensure smooth running of the plant, co-ordinate effective with maintenance department for any break down, utility, services etc. To co-ordinates with Q.C., Store, R&D, Inprocess lab for production related jobs. To ensure that production norms as per laid down procedure are achieved. Through optimum use of resources & report to HOD about the area requiring improvement. To prepare daily logbook containing functioning of the plant in all respects, covering shortage of manpower, incidents of indiscipline if any. To ensure that correct quantity & quality product is charged in safe way. Monitoring of step wise reactions & recording in batch card at the time of operation following cGMP norms. Proper maintenance of production records files & register. Carry out the production related job i.e. raw material, packing material, general material requisition and other requirement through supply chain management system. To identify areas of cost reduction and report to HOD and carry out all functions in cost effective manner. To carry out all operations as per Standard operating procedure. To keep watch on avoiding process deviation. To report all process deviation minor as well as critical through track wise system. To maintain production facilities in clean manner, to carry out disinfections activities in appropriate areas. To make sure that calibration of necessary equipment are done. To make sure that maintenance of equipment & plant is done as per schedule & recorded. To perform SCM & Track wise & validation activity. To ensure review of batch production and control record for its completion. To be a member of team for preparation of BPCR of new product related to plant and also time to time revision of existing BPCR when ever any change / amendment is done through track wise system. To responsible for investigating market complaint and OOS, OOT, Major deviation etc. To conduct the internal, online and self inspection audit as per schedule. To track the BPCR submission after completion of Batch. Manpower handling of respective area as a Plant Incharge. Qualification: B.E./ B. Tech Chemical candidates only. Experience : 18 to 30Years of experience. Interested candidates can sent their CV to jagpal.dewal@ipca.com

Roles Open: QA (QMS, Validations and AQA): Qualifications, Process/Cleaning Validation, QMS (Change Controls, Deviations, CAPA, Complaints, and OOS) RA (Regulatory Affairs): CTD Preparation/Review, Regulatory Queries, Tech Transfer Documents. Required Candidate profile QA Executive / Sr. Executive (QMS & Validations) AQA Executive / Sr. Executive (Analytical QA) RA Executive / Sr. Executive – Regulatory Affairs

Handle quality complaints, aberrations & compliance, Perform RA, RCA, CAPA, Review &approve deviation, batch record, change control, CAPA, SOP, QMS documents, test method, sampling, Vendor Mgt, dispatch, Approve & review validation/qualficn protocols Required Candidate profile M.Sc.(Chem/Pharma) with 4 to 6 yrs exp in API industry. Knowledge of quality systems, legal documentation & Compliance, instrument handling & calibration, Instruments , Root Cause Analysis Techniques

Job Description As an Executive in the Quality Control (QC) division at Lupin Limited's Pithampur-II facility, you will play a crucial role in ensuring the integrity and efficacy of laboratory and manufacturing processes through comprehensive management and enhancement of Labware 7 LIMS (Laboratory Information Management System) implementations. Your responsibilities include overseeing the creation and maintenance of master data, validating system configurations, and managing calculation protocols to ensure precise and accurate data processing. You will engage extensively in documentation management, including crafting and reviewing CSV documentation and test scripts to maintain high standards of system testing and quality assurance. Integration of diverse laboratory instruments with the LIMS landscape will be a key focus, ensuring seamless data flow and system interoperability. Additionally, you will lead troubleshooting efforts and resolutions related to LIMS operational issues, fostering continuous process improvements and minimizing disruptions. You will be responsible for supporting quality assurance initiatives such as QAMS tasks, critical control points (CCP) management, corrective and preventive actions (CAPA), and deviation investigations to uphold stringent compliance with regulatory standards. This role demands collaboration across interdisciplinary teams to maintain process excellence and drive strategic agility in quality management practices. You will contribute to developing talent and nurturing stakeholder relationships while promoting customer-centric approaches aligned with the company's vision for innovation and operational excellence. Joining Lupin Limited offers a dynamic work environment committed to quality, safety, and professional growth, positioning you at the forefront of pharmaceutical quality management and LIMS technology advancements. Work Experience Applicants should possess a solid background with 8 to 10 years of practical experience in Quality Control environments, combined with proven expertise in LIMS implementation and related QC processes. Experience should include working directly with Labware 7 or equivalent LIMS platforms, accompanied by a thorough understanding of laboratory operations, quality compliance, and system validation principles. Proficiency in managing deviations, CAPA, and CCP within regulated pharmaceutical environments is essential. Candidates with hands-on involvement in QC analytical methods, instrument integration, and quality documentation preparation will be well-prepared to excel in this role. Education Post Graduation in Analytical Chemistry Graduation in Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Job Title: QMS Manager Business Unit: Global Quality Compliance Job Grade G10 / Manager 1 Location : Mohali Educational Qualification: M.Sc / B.Pharm / M.Pharm Experience: 12+ yrs Quality Management System 1. Implement, operate, monitor and maintain Quality Systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMPs. 2. Review and Archival of Quality System documents. 3. Follow up for timely closure of Quality Management System documents. 4. Participating in the investigation analysis for Complaints and Audit finding, moreover responsible for providing batch disposition decision as per the outcome of PQC investigation. 5. Supporting in external audits preparations and responding to audit findings. 6. Compilation of the Internal audits response and follow up. 7. Assist in scheduling and preparation of management review meetings. 8. Organize the PQC meeting, coordinate/manage CAPA efforts and interact with customers to conduct complaint investigations. 9. Handling of Change Management System. 10. Assist to author, review and update quality procedures as applicable. 11. Responsible to perform the internal audit as per the site-specific procedure. 12. Responsible for Handling of Complaints, Mock recall/Recall and withdrawal of Drug Products. Preparation & presentation of data for Management Review Board meeting & preparation of MOM for the MRB Meetings.

Designation - Manager - Quality Assurance Company - Leading Pharma Raw Material Mfg. Company Job Location - Dahej, Bharuch Qualification - B.Sc. / M.Sc. / B.E.- Chemical / B.Pharm Experience - Min. 8yrs. and above share with your friends Required Candidate profile company will provide transportation facility from Bharuch. Responsible for handling QA / GMP Related documentation QMS, Audit Preparation, Vendor Questionnaire, Market Compliant & Customer Compliance

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.

Role & responsibilities Handling the Change Control Programme and functional Change Control Coordinator. Handling of Deviation and Market Compliant. Preparation and review of Annual Product Quality Review. Preparation, maintenance, reviews of all other QMS documentation. Handling of RM/PM rejection documents. Preparation and issuance of SOP's. Preparation, Review and Execution of Process Validation Protocol and Report. To Collect and send sample to QC for analysis. To release the product for next stage after receiving QC release report. To maintain logbook and document control. Issuance of format. Reviewing of BMR / BPR. Ensure the implementation and compliance with cGMP aspects. Ensure compliance with Data Integrity. Administrative Reporting to Head QA. All Activity of IPQA

Ensure compliance with GMP & regulatory standards, oversee quality systems, audits & validations, manage QA team, review batch records, handle deviations/CAPA, support regulatory inspections, ensure product quality & safety across manufacturing.

As a part of this role in the pharmaceutical industry, you will be responsible for handling CAPA (Corrective and Preventive Actions), OOS (Out of Specification) incidents, and deviations effectively. Your duties will also include the generation of Standard Operating Procedures (SOPs) to ensure smooth operations within the organization. Additionally, you will be involved in validation processes and maintaining compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). This is a full-time position with a day shift schedule. The ideal candidate should have a total work experience of 1 year in a similar role within the pharmaceutical sector. The work location for this position will require you to be present in person. If you are passionate about maintaining quality standards in the pharmaceutical industry and have the necessary experience, we encourage you to apply for this role.,

You will be responsible for managing the activities of the quality control laboratory to ensure timely delivery of materials for use in production and releases of finished products from the laboratory. Your role includes ensuring testing of stability samples within the structure of timelines identified in relevant SOPs, maintaining laboratory activities on par with compliance expectations, and providing top-notch inter- and intra-department customer service. With at least 8 years of experience in a laboratory related to a cGMP/Pharmaceutical environment, including a minimum of 4 years in a Supervisor capacity, you will manage the day-to-day operations of the Quality Control laboratory. This involves setting and communicating priorities based on the production schedule and maintaining knowledge of the potential impact of Quality Control activities on activities in other departments. It is essential to effectively communicate this information to the appropriate personnel in a timely manner. Your responsibilities will also involve managing and enforcing laboratory GMP systems to ensure they are adequate, sustainable, and being followed. You will update Laboratory Procedures (SOPs) and Policies, interpret SOPs/Methods/Specifications, and provide clarity as needed. Additionally, you will manage and perform investigations of out-of-specification laboratory results, ensuring that all investigations proceed logically, orderly, and in a timely manner. You will need to review and sign off on various reports and certificates to ensure compliance with specifications. Specialized knowledge in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC), dissolution, disintegration, and moisture determination is required. Understanding and explaining compendial (USP/BP/EP/JP) procedures, identifying and troubleshooting instrument-related and procedure-related problems, and effectively planning and organizing multiple tasks with a high degree of complexity are essential skills for this role. You must be able to work in a cross-functional team setting, either as a leader or a member, with a complete understanding of team goals. Resolving conflicts between employees within and between departments and applying cGMP requirements applicable to pharmaceutical quality control laboratory are key aspects of this position. Proficiency in areas such as Laboratory Data Management, Stability Study Documentation, Analytical Method Validation Documentation, and GMP Compliance is required. A Bachelor's Degree (B.Sc) in Chemistry or related field is required, while a Master's Degree (M.Sc) in Chemistry or related field is preferred. A minimum of 12-15 years of experience in an injectable QC Department is necessary for this role. Internal candidates applying for this job role must have completed a minimum of 2 years in their existing role.,

You will be working in the Store & Warehouse department as an Assistant Manager, reporting to the Department Head. Your main responsibilities will include dispensing raw materials according to standard operating procedures, ensuring compliance with cGMP regulations, and maintaining cleanliness and sanitation in the raw material dispensing area. You will be required to perform daily verification of weighing balances, record temperature and humidity levels, and ensure the proper cleaning and operation of equipment such as vacuum cleaners and barcode scanners. Additionally, you will be responsible for calibration of balances, segregation of dispensed materials for different batches, and issuing additional materials as per approved requests. In the warehouse, you will be involved in tasks such as preparing goods receipt notes, generating material detail labels through SAP, and conducting stock transfers to other plants. You will also be responsible for periodic stock verification, reviewing daily balance verification, and maintaining proper storage and segregation of materials. Furthermore, you will need to handle tasks related to damaged or expired materials, coordinate with quality control and assurance departments, and ensure the cleanliness and housekeeping of the warehouse. You will also be involved in dispatching finished goods, reconciling stock with SAP, monitoring daily temperatures, and initiating change controls or deviations when necessary. Training subordinate staff, interacting with auditors, preparing SOPs, and handling various documentation tasks will also be part of your responsibilities. You may be assigned additional duties by the department head as needed and will need to maintain accurate records, perform SAP transactions, and ensure compliance with all relevant procedures. If you have any queries or need further clarification, please feel free to reach out to dipak.panchasara@zyduslife.com.,

You are invited to attend a walk-in interview for Zydus Animal Health Unit in Ahmedabad on 03rd August 2025 at Hotel Woodlands, NH 8, Near Tejpal Motors, Balitha, Vapi, Gujarat 396191. The interview timings are from 9:00 AM to 04:00 PM. The job location is Pharmez Matoda, Ahmedabad. In the Manufacturing (OSD) Department, we are looking for candidates for the following roles: 1. Officer/Executive: - Qualification: B. Pharma/M. Pharma - Experience: 2 - 7 years - Responsibilities: - Planning manufacturing batches in coordination with PPMC - Monitoring line clearance, cleaning of equipment, and instruments - Performing qualification activities - Initiating QMS activities such as change control, deviation, CAPA, and investigation - Handling manpower and allocating daily activities 2. Plant Operator/Technical Assistant: - Qualification: ITI/Diploma - Experience: 3 - 8 years - Responsibilities: - Operating machines like Granulation (Glatt, GEA), Cadmach Roll Compactor, and Compression machines (Cadmach-26STN) - Performing line clearance, operation, and cleaning of equipment/instruments/auxiliary items In the Engineering Department, we have openings for the following positions: 1. Sr. Executive/Executive: - Qualification: BE/B.Tech - Experience: 3 - 8 years - Responsibilities: - Managing Utility Operations like HVAC, Chiller, Air Compressor, Cooling Towers, and Boiler Operations - Handling Process Equipment maintenance and Plant maintenance activities - Implementing QMS 2. Plant Operator/Technical Assistant: - Qualification: ITI/Diploma in Engineering - Experience: 2 - 8 years - Responsibilities: - Managing machinery breakdowns, executing preventive maintenance, and ensuring uninterrupted production processes - Handling water system operations and electrical maintenance - Performing civil work like painting, plumbing, and building maintenance If you have the required qualifications and experience for any of the mentioned roles, we look forward to meeting you at the walk-in interview to discuss your potential contribution to our team at Zydus Animal Health Unit in Ahmedabad.,

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.