701 Capa Jobs - Page 11

Key Responsibilities: 1. QMS Implementation & Oversight: Maintain and continually improve QMS elements such as deviation handling, change control, CAPA, OOS/OOT, risk assessments, and quality reviews . Ensure compliance with GMP, GAMP, ISO, ICH (Q9, Q10), and regulatory agency requirements (e.g., USFDA, MHRA, WHO, EU GMP) . 2. Deviation & CAPA Management: Investigate deviations in manufacturing, QC, and support areas. Perform root cause analysis (RCA) and drive timely and effective CAPA implementation. Monitor the closure timelines and effectiveness verification of CAPAs. 3. Change Control & Document Control: Evaluate and manage changes in equipment, facility, process, and documents. Review and manage controlled documents including SOPs, protocols, risk assessments , etc. Ensure document lifecycle management in compliance with GDP . 4. Audit Readiness & Regulatory Compliance: Support internal audits, regulatory inspections, and third-party audits. Prepare and maintain audit documentation, observation responses, and compliance tracking . Coordinate self-inspections and site quality risk assessments . 5. Training & Quality Culture: Conduct GMP training programs related to QMS and quality culture. Monitor training compliance across functions and maintain training matrices. 6. APQR/PQR & Quality Metrics: Participate in the preparation of Annual Product Quality Reviews (APQRs) . Compile, monitor, and report Quality KPIs and metrics to management. 7. Sterile Manufacturing Support: Ensure QMS processes support sterility assurance practices. Review and ensure compliance for media fill protocols, aseptic area controls, and environmental monitoring deviations.

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Experience 4 - 10 Years Industry IT Software - QA Testing Documentation Qualification M.Sc Key Skills Pharmaceutical Agro Chemical Quality Assurance Quality Assurance Analyst QA MSC Chemistry Chemical Agrochemical Quality Agreement GMP Guidelines

As a Quality Assurance Officer in the IT Shared Service Center, you will be responsible for ensuring the quality of our software products and services. You will be involved in all stages of the software development process, from initial specification to final release. Your primary goal will be to ensure that our products meet the highest standards of quality and provide a seamless experience for our users.

JD: 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per seniors guidance. 5) To be prepare cleaning validation protocol and report as per seniors guidance. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 17) To be controlled all master documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products. 20) Preparation of documents for Certification & product registrations work i.e. FDA, Halal, Kosher, Reach. etc. Review specification, test procedure and SOP's for their deficiencies according to audit points 1) To be prepared document related to audit as per audit agenda. 2) Filled vendor questionnaires & prepared related documents. 3) Keeping record of key Customer. 4) To be prepared process validation protocol and report as per senior’s guidance. 5) To be prepare cleaning validation protocol and report as per senior’s guidance. 6) To be conduct training and evaluation done as per Schedule. 7) To be prepared master, controlled, uncontrolled, reference, obsolete & distribute documents as per SOPs and formats requirement. 8) To help the senior for preparation of CAPA according to audit report. 9) Issuance of Change control, OOS, deviation & other QMS formats whenever required from respective department and retained record in logbook. 10) To be prepared BPCR as per procedure. 11) To be issue BPCR to all blocks as per prerequisite. 13) To be prepared data for monthly report as per QMS and submit to senior. 14) To be handle change control, market complaint, deviations, CAPA. 15) To be issue documents, protocols, log book and format to all department as per prerequisite. 16) Retrieval of documents. 18) To be prepared schedule & conduct Internal audit. 19) To be prepared APQR of all products.

Position: Contract Engineer Project portfolio and Quality Key Purpose of the Job: As a member of the Project Management team, the Contract Engineer will facilitate project gate reviews, act as a project scheduler, and consolidate gate meeting outcomes (GO/NO GO). The role involves monitoring risk assessments, advising project teams on gate outcomes, and ensuring adherence to quality standards at each project stage. The engineer will also support project quality initiatives, certification processes, and problem-solving methodologies such as 8D and ISO standards Key Responsibilities: Facilitate project gate reviews and consolidate outcomes. Act as a project scheduler and ensure alignment with established processes. Monitor and follow up on project status with various stakeholders. Ensure projects meet defined quality criteria at each stage. Support project quality initiatives, including certification and audits. Apply problem-solving methodologies (8D, RCA, CAPA, 7QC tools). Conduct risk assessments and support mitigation planning. Collaborate with cross-functional teams including sales, engineering, manufacturing, and supply chain. Support ISO 9001:2015 internal audits and compliance. Manage KPIs, MIS reporting, and participate in Management Review Meetings (MRM). Qualifications: Bachelors degree in Mechanical, Industrial, Mechatronics or Electronics Engineering. 3-5 years of relevant functional experience in a similar role. Key Skill & Knowledge Profile Strong knowledge of project scheduling and stage gate processes. Experience in an OEM environment with cross-functional collaboration. Understanding of manufacturing processes and terminology. Familiarity with project quality standards and tools (8D, 7QC, RCA, CAPA). Knowledge of ISO 9001:2015 and internal audit procedures. Proficiency in MS Office and project management tools. Strong communication and interpersonal skills. Self-motivated, detail-oriented, and capable of working in a fast-paced environment. Project Management Certification (not mandatory).

Pl join us my whatsup group no 9356395439 Post - Quality & MR CNC & VMC Production line Current Position Asst Manager or Sr Engineer Directly F2F interview availability Pune chakan Industry automotive Machine Shop Age Max 40 yrs Qualification – Any graduate or DME / BE /BTECH Experience – 8- 12 years in CNC & VMC Production line Sound knowledge and experience in ISO & IATF 16949 .• Communication skill in English must speak, writing . *Automotive experience* is must. Person must have *sound knowledge in 7 QC TOOLS . APQP, PPAP , 8D CAPA , CPK study Mass production and daily dispatch experience is preferred. Person should have ability to lead the team of 25+ workman*

Sr. Exe AM Business Excellence- West: About CMR: CMR Green Technologies Limited formerly known as Century MetalRecycling Limited is Indias largest producer of Aluminium and Zincdie-casting alloys with a combined annual capacity of over approx. 4, 18, 000MT per annum. Since its inception in 2006, it has maintained itsfast-paced growth by leveraging the latest technology and continuousimprovement. CMR, which recycles aluminum scrap to make alloy, has 28-30 percent market share in India and is nearly three timeslarger than its nearest competitor. We are having strong presence at PANIndia level (North, West & South) with 13 manufacturing units, 5000 strongworkforce and supplies to major automotive industry in India includingtier one OEMs like Maruti Suzuki, Honda Cars, Bajaj Auto, Hero MotoCorp andRoyal Enfield Motors. Halol & Other West locations Position: FLO Business Excellence Job Band: - A Designation: Executive/Sr. Executive/AM No. of Posts: 01 Department: Business Excellence Reporting to: Area Head BusinessExcellence Qualification: Essential B.Tech/M.tech Mechanical/Electrical/ Electronics/ Metallurgy/ Industrial Engineering Desired: - Degree/Diploma/Certification Course in Production / Experience: Essential: - 3 or more years of experience inBusiness Excellence / Industrial Engineering/ Process Engineering. Desired: - Experience in process improvement, project management, and data analysis, Lean six sigma, 7 QC tools, CAPA, RCA. Job Profile: Review and analyze identified areasof improvement for preparing recommendations on feasibility and scale of theproject. Coordinate with department headsfor conducting audits in energy consumption / maintenance / safety standards, report findings and consequently scope of improvements. Identify process improvementopportunities out of suggestions received from audit findings, Qualityobservations / audits, kaizens, process improvement teams, user departments, ERP, EHS teams, etc. Propose and evaluate feasibility of implementing bestpractices in functions in line with changing external environment CoreCompetencies: Leanmanufacturing, six sigma, 7QC tools, PLC controlling and automations. Costconsciousness Effectivecommunication Teamwork Knowledgesharing and learning. Planningand organization Executionexcellence Resultsorientation General: Age- 25 -30 Years CTC Approx. 3-6 LPA Approx. CTC not a constraintfor suitable Candidate Candidate should not be a frequent Changer. Notice Period: Joining Period Max 30 Days. Wecan Buy Notice Period if required. Location: Vanod :Survey No. 470 & 471, Village Vinod, Taluka Dasada, District SurendraNagar, Gujarat 382750 Railway Station: Surendranagar (93.5km away) Airport: Sardar Vallabhbhai Patel InternationalAirport (104.1 km away) Halol: 455/P1/P1, Village Kambola, Taluka- Savli, Vadodara, Gujarat, India-391510 NearestRailway station: Champaner Railway Station (11.5km away) VadodaraRailway Station (41.5km away) Airport: Vadodara Airport, Gujarat (36km away)

Job Title: Assistant / Deputy Engineer - Production Job Description: We are looking for a skilled and dedicated CNC Programmer Rolling professional to join our team. The ideal candidate should have strong experience in CNC programming and rolling operations, with a keen focus on productivity, quality, safety, and team development. Key Responsibilities: Ensure effective utilization of available resources and release of products within 48 hours. Allocate machines/lines as per Preventive Maintenance (PM) schedules and resolve pre-identified issues. Maintain and update production documents such as hourly production track sheets, layer audits, shift reports, CAPA, and scrap handling records. Ensure quality standards are met, including functioning of poka-yoke mechanisms and monitoring of rejections. Monitor and ensure all process and product parameters remain within specification. Promote and enforce safety practices (PPE usage, identification of Unsafe Acts & Conditions, accident prevention, and engineering controls). Implement 5S, QCC, suggestion schemes, and Jishu Hozen (JH) concepts across the section. Assess skill levels of operators, arrange internal/external training, and manage manpower deployment accordingly. Track manpower retention weekly and engage in motivating operators. Must-Have Skills: CNC Programming Rolling Operations

Your key responsibilities: Supervise and manage the sutures production area to ensure quality products are made and production targets are met. Ensure strict adherence to GMP/GDP/ISO13485/FDA regulations, as well as ISO 45001 (OHS) and ISO 14001 (Environmental) management systems. Monitor and improve operator productivity and efficiency through continuous oversight, counseling, and training. Maintain accurate production documents and enforce all safety and hygiene procedures within the department. Be willing to work all shifts, including nights, and undertake significant domestic and occasional international travel for training or work. What you will bring to the team: Diploma / B.Tech / Bachelor of Mechanical or Bio Medical Engineering 5 8 years of experience of experience in medical device Industry. Experience to Handle the Manpower and effective Production Planning. Knowledge in ISO 13485, ISO 14001, and ISO 45001. Must have good working knowledge in MSOffice.

Your key responsibilities: Supervise and manage the sutures production area to ensure quality products are made and production targets are met. Ensure strict adherence to GMP/GDP/ISO13485/FDA regulations, as well as ISO 45001 (OHS) and ISO 14001 (Environmental) management systems. Monitor and improve operator productivity and efficiency through continuous oversight, counseling, and training. Maintain accurate production documents and enforce all safety and hygiene procedures within the department. Be willing to work all shifts, including nights, and undertake significant domestic and occasional international travel for training or work. What you will bring to the team: B.Tech / Bachelor of Mechanical or Bio Medical Engineering Experience to Handle the Manpower and effective Production Planning. Knowledge in ISO 13485, ISO 14001, and ISO 45001. Must have good working knowledge in MSOffice.

Role & responsibilities To be well versed about coordination and collaboration with Quality functions of third party manufacturing (CMO) sites and CMO team for compliance of product, facility, systems, procedures. and for documents required from third party for various purpose; review, RA submission etc. Must have knowledge and know how on regulatory pathway for registration of product as per third party and or loan license norms/rules and requirement of documentation for regulatory submissions. Incumbent is expected a good reviewer and investigator To know the function of oversight of CMO sites for batch/lot releases as applicable form the manufacturing (Feed supplements and Pharma products facilities for update on compliance of system, procedure, systems) To be well versed with vendor qualification procedures and must be experienced in conducting audits/inspections at CMO sites for qualification and compliance To verify CoA for in line with product specifications and CoA. To verify and to confirm stability study of finished products and to coordinate for documents of stability, RM, PM, product specifications, CoA. To identify Govt. approved third party labs for testing of RM, PM (if any) and finished product and to support CMO-QA for Qualification of vendor (Third party lab/service provider) To review batch documents and test analysis reports of batches /lots executed in line with established batch formula and test method/product specification To be well versed and possessing know how of establishing Quality Function (QA & QC) for CMO Function To perform investigation related to product complaints, observations/notices and to collaborate and coordinate with CMO function and Quality function of third party manufacturing site for root cause analysis and CAPA actions To possess knowledge on quality management system such as change management, complaint handling, CAPA procedures, recall procedures, regulatory queries responding and handling of queries from customers and market. To be well versed with procedures of artwork (PPI & label etc.) preparation, review and approval To have very good operational knowledge of computer: Microsoft word, excel and any other software based task related to CMO-QA function To coordinate with sourced lab and third party manufacture for timely completion of testing of routine batch(s) and testing of samples as part of investigation and for timely responses on queries and product complaints To possess very good communication skills, willing to travel as part of job role Job Location: Kadi,Gujarat ( Bus facility available from Ahmedabad,Kalol & Kadi)

Review& execution of SOP, Master BMR& BPR,Qualification document& Validation Document review of Executed BMR/BPR. Change control, CAPA, Risk assessment related to shop floor QA SOPs &IPQA related Documents. Required Candidate profile 1.Officer–IPQA Injectable Manufacturing 2.Sr. Officer– IPQA Injectable Deviation, Change control,Market Complaint & CAPA of respective shop floor area prepare the QA SOPs and IPQA related Documents

Drafting and adherence to Quality Assurance Procedures including: Standard Operating Procedures & Work Instructions Change Control Process Validation Document Control. cGMP Compliance Planning and Co-ordination for External and Internal Audits Ensure that CAPA and adhered for Nonconformances Investigate and Review Customer Complaints Training to stakeholders w.r.t. updated procedures and compliances IMS, TQM and 5S Procedures and compliances Desired Candidate Profile Ideal candidate must be a Full Time M.Sc. (First Class) in Chemistry/Industrial Chemistry with 8-11 years of experience in QA Function in a Chemical/API manufacturing plant

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

B.Sc. / M.Sc. with 3 to 4 years of experience in pharmaceutical industry. Experience of CAPA, change control, QMS, Documentation, SOP Preparation, IPQA, BMR issuance and review, Equipment qualification, GMP/GDP documents, etc. Required Candidate profile To ensure Q. A. activities are carried out as per set procedures and ensure to record in respective documents. Preparation and review of equipment and utility qualifications documents. Perks and benefits Negotiable - Depending Upon Candidate & Experience

JOB DUTIES AND RESPONSIBILITIES (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processes. 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility

Manage release of product batches, including owning the QA product release workflow in SAP. Lead and supervise a team of QA professionals to perform operations as described above. Review and approve Purchase Specifications and Analytical Standards Required Candidate profile Work to create an environment of open communication, participation &information-sharing within & between teams within QA &throughout facility Pls mention this Feel free to reach me email Visit our website for more details: Follow Capital Placement Services Linkdein Profile for more updates :

Job Duties and Responsibilities (Please Mention In Below Table) 1 Manage release of product batches, including owning the QA product release workflow in SAP. 2 Lead and supervise a team of QA professionals to perform operations as described above. 3 Review and approve Deviation and Laboratory Investigations 4 Review and approve Purchase Specifications and Analytical Standards 5 Review and approve Issue Reviews and CAPA 6 Assist with Non-Conformance Investigations and provide guidance in identifying potential product impact and determination of final product disposition 7 Review and update Standard Operating Procedures (SOPs) for GMP compliance 8 Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function Review validation protocols and completed documents, including process qualification protocols for validations of commercial processe 9 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 10 Work to create an environment of open communication, participation and information-sharing within and between teams within QA and throughout facility 11 Assist with complaint investigations for internally produced commercial product 12 Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable). 13 Ensure all work is performed and documented according to approved standard operating procedures, in general compliance with cGMPs and in a timely manner consistent with agreed upon schedules

Division Department Sub Department 1 Job Purpose Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines Key Accountabilities (1/6) Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner Collect data from all SPOCs with respect to received work plan for review Escalate any delays in receiving response from unit with respect to work plan Review of collected data for work plan fulfilment Send data to HO for compilation of deficiency response Take follow up with HO to receive updated dossier for product updates Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies Review master validation protocol and report within timeline Check major observation in other units documents also for improvement of validation documents at site Synchronize all units Validation documents for improvement of all units Key Accountabilities (2/6) Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness Collect APQR timely with units for review Review data with supporting documents for data authentication Check major observation with other units for improvement of documents at site Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement Review and compile received technical agreements for comments Provide guidance for execution of batches and handling events as per customer requirement Provide training in department to improve awareness in audit and compliance with licencing department Take follow up with HO for providing fresh TA and pending TAs for products Key Accountabilities (3/6) Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site Update site on receipt of documents for handling execution of customer or market specific batches Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements Inspect audit prerequisites to support and prepare for external audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Prepare and submit EPA annual production application for getting the establishment registration of unit V Key Accountabilities (4/6) Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning Coordinate with units for all the raw data, its review and finalization before submission to corporate Prepare pre-inspection compliance report after announcement of MHRA audit Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP Prepare and update procedures in line with current GMP requirements Key Accountabilities (5/6) Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements Collect, review and finalize applications for: Additional Product COPP Test License Renewal of drugs manufacturing license and WHO GMP certificate All certificates for product registration and tender Alcohol Quota FDA Staff Approval Site Layout Approval Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval Communicate with FDA to resolve queries and follow ups to monitor status of application Review, maintain and distribute approved certificates to concerned stakeholders at site Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition Key Accountabilities (6/6) Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits Coordinate with Units for preliminary draft response and prepare final draft within timeline Follow up for closure of compliance commitments Provide adequate, errorless and timely compliance to CQA Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review Major Challenges Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation with units timely with resolving strategy Lack of detailed compliance with appropriate root cause from user department Regular discussion and trainings is provided to unit Liaising with Government officials for availability and timely approvals of applications Key Interactions (1/2) SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month) SPOCs of APQR at site for timely review of APQR (monthly) SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly) Unit QA heads in reference to audit readiness and preliminary draft response (need basis) CQA and A&C team for final draft response review (need basis) Key Interactions (2/2) FDA for processing and approval of application (need basis) Dimensions (1/2) Zero overdue compliance of deficiencies 100% adherence to provided timelines for review of documents timely Track and support in Top 07 projects Timely and errorless review of APQR at site Review should not exceeding 15 days from schedule Ensure quality score minimum of 90% for each month Timely and errorless preparation of tech transfer summary for site Data submission to corporate should not go beyond 5th of every month Average 30 audits/ year 100% adherence to timeline of compliance for various regulatory and customer audits No disruption is supply chain because of GMP approvals, product deficiency and product license For FDA: Approximately 150 additional product license 36 test license 40 certificates 290 COPP 5 staff approvals Dimensions (2/2) Key Decisions (1/2) Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA) List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA) Recommend to update correct data provided for deficiency response (To HO) Process of identifying root cause for the observation in various inspection and audit (to CFT) Key Decisions (2/2) Education Qualification Pharma/ M Licensing and registration (0-2 years) Relevant Work Experience Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system Show more Show less

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in CSV and excellent leadership skills. Roles and Responsibility Lead the development and implementation of CSV strategies to ensure compliance with regulatory requirements. Collaborate with cross-functional teams to identify and mitigate risks associated with CSV. Develop and maintain relationships with key stakeholders, including regulators and industry partners. Provide training and guidance on CSV best practices to team members. Conduct audits and assessments to ensure adherence to CSV standards. Develop and implement process improvements to enhance CSV efficiency and effectiveness. Job Requirements Strong knowledge of CSV principles and regulations, including FDA guidelines. Excellent leadership and communication skills, with the ability to motivate and guide team members. Experience working in a fast-paced environment with multiple priorities and deadlines. Strong analytical and problem-solving skills, with attention to detail and the ability to identify risks. Ability to work collaboratively with cross-functional teams, including sales, marketing, and engineering. Strong understanding of quality management systems and ISO standards. Location- Bengaluru,Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli, Jammu, Lakshadweep, Nagar,New Delhi,Puducherry,Sikkim

01 Managing the entire QA activities in the plant & Overall implementation of Quality Systems in all units. 02 Design, Develop and approve all Quality systems in all units. Monitoring, Documentation, and implementation of process development. 03 Responsible to handle regulatory audits USFDA ISO 9001-14001, EU,WHO, and their compliance in all units without any Major Non Compliance. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate; and Performing product quality reviews 04 Handling of statutory audits like Quality, EHS, KSPCB, -CDSCO, weight & scale inspector, Director of Factories & Boilers, Social audits etc and their compliance (Evaluated by No show cause notice and no complaints) 05 Making sure that critical deviations are investigated and resolved; 06 Approving all specifications and master production instructions, Test methods, Qualifications 07 Approving all procedures impacting the quality of intermediates or APIs 08 Making sure that quality related complaints are investigated and resolved 09 Adhering to QA budget. 10 To qualify company for various certifications. 11 Assuring QMS in all Units. Experience 15 - 20 Years Salary Not Disclosed Industry Pharma / R&D / Biotech Qualification B.Pharma, M.Sc Key Skills Quality Assurance Supervisor USFDA Compliance and Audits Pharmaceutical Quality Assurance