243 Ipqa Jobs - Page 9

Greetings!!! We are seeking for a QA Validation (Dy Manager/ Manager )_Injectables for a Pharma Company at Chennai Location. Job Responsibilities: Responsible to ensures the quality and compliance of injectable products through validation and qualification activities, reviewing documentation, and conducting audits, all while adhering to GMP and regulatory requirements. Key Responsibilities: Validation and Qualification: Executes and reviews qualification/re-qualification and validation activities for equipment, systems, facilities, and plant utilities. Prepares and reviews validation/qualification protocols and reports. Conducts sampling activities as per protocols, including process and cleaning validation. Ensures all equipment, systems, and processes are validated and qualified according to GMP and regulatory standards. Documentation and Review: Reviews and approves validation lifecycle documentation (e.g., URS, DQ, FAT, SAT, IQ, OQ, PQ, PV) protocols and reports. Maintains validation registers. Reviews and approves validation deviations. Ensures all documentation is complete and accurate. Quality Assurance: Conducts quality assurance audits and inspections. Identifies and addresses potential quality issues. Ensures adherence to GMP and regulatory requirements. Participates in investigations and CAPA activities. Interested Candidates Kindly share your updated cv to khyati@bvrpc.com

Role & responsibilities Lead a team of QA professionals to manage QA oversight to Manufacturing process operations. Provide leadership for lot release, incoming quality, manufacturing, and labs investigations, change control and corrective and preventative action review/approval, manufacturing support, record review/approval, and ongoing projects support etc. Support team by guidance and coaching and provide direction/approval of activities and decisions. Coordinate planned external audits and drive Internal Audit plan and share reports and outcome to the Site Management Team proposing continuous improvement action plan Analyze trends, quality metrics and other data to identify quality and compliance gaps. Manage release of product batches, including owning the QA product release workflow in SAP. Develop and maintain a Quality Management System in accordance with domestic and international regulatory requirements Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements. Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at third parties , based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product. Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material. Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them. Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods. Responsible for periodic review of SOP s, specification and standard operating procedure. Responsible for trouble shutting of analytical instruments. Responsible for Quality training initiative (GMP) across the site. Candidates must have experience HVAC validations . Candidates must have experience in microbiology sections . Candidates must have experience in handling of BMR, BPR,IPQA. Candidate worked regulatory environment like WHO-GMP, MHRA,EU-GMP etc. Candidates must have experience FDA license registration process Candidates must have experience in dossiers preparation.

ASTER DM HEALTHCARE LIMITED is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey. Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

We have been retained by a highly reputed and fast growing Pharma Company to hire "Senior Manager- QA" to be based at their plant located at Aurangabad. Details of the position are mentioned below: Company: Our client is a highly reputed and fast growing Pharma Company. Company's products enjoy a very high degree of acceptance from doctors within India as well abroad. The company has their manufacturing units spread across different locations in India. The sales turnover of the company is more than 700 Crores. Designation: Senior Manager - Quality Assurance (Formulation Unit manufacturing Oral Solid, Liquid Oral & Sterile Injectables) Educational Qualification: M.Sc. / M. Pharma Experience: Minimum of 10 to 15 years of experience of handling QA function of a reputed Pharma Company. Besides QA, the candidate must have basic understanding of QC function also. The incumbent shall have the experience of working as Deputy Manager / Manager QA or above level in a reputed Pharma Company for at least 3 years Job location: Aurangabad Those of you whose profile matches the above mentioned description and will like to apply for this position shall forward their updated profile to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile: 98202 34987 / 81307 24980

Role & responsibilities 1. Line Clearance in all stages. 2. Sampling all stages. 3. Validation. 4. Control Sample Management 5. APQR 6. QMS Review. Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982

FinAdvantage is looking for Senior Executive to join our dynamic team and embark on a rewarding career journey Leading the full audit cycle by checking tax compliance, verifying financial records, and inspecting accounts. Analyzing the results of the audit and presenting possible solutions for ineffective financial practices to management. Evaluating company accounting procedures, payroll, inventory, and tax statements to guide financial policymaking. Conducting risk assessments to recommend aversion measures and cost savings. Following up with management to ensure remediations are implemented into the company's financial practices. Supervising junior auditing personnel and implementing their research work into the auditing process. Preparing and reviewing annual audit memorandums. Researching applicable federal and state laws and regulations to ensure the company's books are compliant.

Responsibilities: Conduct FG (Finished Goods) Inspection in the warehouse and promptly communicate relevant observations to the concerned vendor. Ensure timely dispatch of FG samples for testing and review the testing reports upon receipt. Prepare monthly reports summarizing findings from FG inspections. Efficiently handle market complaints, ensuring closure within stipulated timelines. Demonstrate a comprehensive understanding of current cGMP and FSSAI norms. Possess knowledge of In-Process Quality Assurance (IPQA) procedures. Willingness and readiness to travel as required. Qualifications: Bachelor's degree in a relevant field. Proven experience in quality control within the manufacturing or related industry. Familiarity with cGMP, FSSAI norms, and IPQA. Strong attention to detail and analytical skills. Excellent communication and interpersonal abilities. Ability to meet deadlines and work effectively in a team.

To lead IPQA (In process Quality Assurance) Team and its monitoring by assigning tasks for IPQA chemists in day to day activities. Participating, reviewing and approval of protocol and reports of user requirement specifications, qualifications, validations, risk assessment and any other study to be performed at the site. To ensure the commitments (marketing authorization and the manufacturing authorization requirements) given to regulatory authorities for the products have been met for the batch concerned. To participate in designing, developing, approving and implementation of the quality systems at the manufacturing site. Participate in the external inspections of the manufacturing site, prepare Corrective and Preventive Action (CAPA) plan for observations and monitor its implementation. Review of Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports. Participate in the investigation of complaint, deviation, change control, non conformance, incidence, returned goods, product recall, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of Corrective and Preventive Action (CAPA). Participate in self inspection and implementation of its observations. Review of training manual and provide training on cGMP and quality systems Overview of Product Quality Review (PQR) and approval of its reports. To oversee that quality systems, procedures, validation master plan, site master file, quality manual and such documents are maintained in current state and implemented effectively. Preparation of Monthly MIS report including IPQA activities for QA Department. To look for continuous improvement. To approve documents in the QUANTUM software after approval of Head QA or Designee . To oversee the fulfillment of regulatory requirements of RA department. Releasing or rejecting all finished products in absence or direction of Manager QA. Responsible for Ensure the control sample and stability samples of finished product and submission to the QC for analysis Review of Standard Operating Procedures (SOPs) and guidance to the junior in preparation of SOPs. Perform vendor audit for starting material and packaging material vendors; external testing laboratories and other service providers. Coordination with formulation and development department for new product introduction at facility or change in product process or formula. To oversee analytical method validation and verification activity. The additional responsibilities shall be delegated on day to day basis under authorization of Manager-QA. Pedigree B.Pharm/ M.Pharm with minimum 12 years of relevant experience in IPQA department

To lead IPQA (In process Quality Assurance) Team and its monitoring by assigning tasks for IPQA chemists in day to day activities. Participating, reviewing and approval of protocol and reports of user requirement specifications, qualifications, validations, risk assessment and any other study to be performed at the site. To ensure the commitments (marketing authorization and the manufacturing authorization requirements) given to regulatory authorities for the products have been met for the batch concerned. To participate in designing, developing, approving and implementation of the quality systems at the manufacturing site. Participate in the external inspections of the manufacturing site, prepare Corrective and Preventive Action (CAPA) plan for observations and monitor its implementation. Review of Out-Of-Specification (OOS) and Out Of Trend (OOT) investigation reports. Participate in the investigation of complaint, deviation, change control, non conformance, incidence, returned goods, product recall, vendor audit, external testing laboratories audit; its impact assessments; review its reports and monitor the implementation of Corrective and Preventive Action (CAPA). Participate in self inspection and implementation of its observations. Review of training manual and provide training on cGMP and quality systems Overview of Product Quality Review (PQR) and approval of its reports. To oversee that quality systems, procedures, validation master plan, site master file, quality manual and such documents are maintained in current state and implemented effectively. Preparation of Monthly MIS report including IPQA activities for QA Department. To look for continuous improvement. To approve documents in the QUANTUM software after approval of Head QA or Designee . To oversee the fulfillment of regulatory requirements of RA department. Releasing or rejecting all finished products in absence or direction of Manager QA. Responsible for Ensure the control sample and stability samples of finished product and submission to the QC for analysis Review of Standard Operating Procedures (SOPs) and guidance to the junior in preparation of SOPs. Perform vendor audit for starting material and packaging material vendors; external testing laboratories and other service providers. Coordination with formulation and development department for new product introduction at facility or change in product process or formula. To oversee analytical method validation and verification activity. The additional responsibilities shall be delegated on day to day basis under authorization of Manager-QA. Pedigree B.Pharm/ M.Pharm with minimum 5-8 years of relevant experience in IPQA department

Conduct in-process quality checks at various stages of manufacturing, including sampling, inspections, and testing, to ensure compliance with SOPs and regulatory requirements. Review and compile complete batch records (BMR and BPR) prior to release. Monitor steps followed in manufacturing and packing are as per standard operating procedure. Ensure all instruments are calibrated and validations are carried out in timely manner. Issue Validation Protocol, Method Validation Protocol, URS Qualification as per the schedule. Monitor critical process parameters, such as temperature, pressure, pH, and mixing times, to ensure they are within specified ranges. Review and approve batch records, manufacturing instructions, and other relevant documents to verify compliance with established procedures and specifications. Perform line clearance activities to ensure proper segregation and cleanliness of manufacturing areas, equipment, and materials. Collect and analyze samples during production runs for physical, chemical, and microbiological testing as per defined sampling plans. Withdraw stability sample control samples for analysis at intermediate and finished product stage. Issue, Review Maintain Change Control of Site, Corporate their respective logs. Issue controlled copies and retrieval of old RMS, FPS, SPS, PMS, RM PM Item Code List. Coordinate with the quality control (QC) department for timely testing and release of in-process samples. Investigate and document deviations, non-conformances, and out-of-specification results, and collaborate with the appropriate teams to identify root causes and implement corrective actions. Assist in the implementation and maintenance of quality systems, including change control, risk assessment, and document control. Support internal and external audits by providing necessary documentation and participating in audit activities. Collaborate with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to resolve quality-related issues and drive continuous improvement initiatives. Maintain accurate and up-to-date records of all IPQA activities and documentation, ensuring compliance with GMP (Good Manufacturing Practices) and other regulatory guidelines. Identify and report the non-compliances observed in individual departments. Issue controlled copies retrieval of old SOPs and QAPs. Handling of Deviations CAPA. Handling / investigation of product complaints, incident reports, batch failures and product recalls. Preparation, Updation, issuance, retrieval of Price list. Document submission as per Regulatory requirement. Any other assignments allocated by Unit QA from time to time responsibilities Stay informed about current industry practices, regulatory requirements, and quality trends to enhance IPQA processes. Pedigree B.Pharm/ M.Pharm with minimum 1-3 Years of experience in IPQA

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

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

Project Role : Operations Engineer Project Role Description : Support the operations and/or manage delivery for production systems and services based on operational requirements and service agreement. Must have skills : Rockwell Automation FactoryTalk PharmaSuite Good to have skills : NA Minimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Pharmasuite MES Architect, you will be responsible for designing, developing template based MES recipes in Rockwell FactoryTalk PharmaSuite (FTPS) to support pharmaceutical manufacturing processes. You will collaborate with cross-functional teams to ensure efficient recipe authoring and seamless integration with automation and enterprise systems while adhering to regulatory and industry standards. Roles & Responsibilities:-Develop MES recipes using Rockwell FTPS, ensuring compliance with industry best practices.-Design and implement building blocks for reusable recipe structures.-Work closely with process engineers and manufacturing teams to map end-to-end pharmaceutical processes, with a focus on biologics.-Ensure compliance with pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).-Participate in the full MES lifecycle, from design and validation to deployment and support.-Perform recipe testing, troubleshooting, and validation in alignment with SDLC (Software Development Life Cycle) methodologies.-Collaborate with DCS teams to ensure seamless MES-DCS integration for automated manufacturing.-Support and maintain MES systems in a validated state, ensuring high availability and performance.-Provide technical expertise in MES implementation and contribute to continuous improvements in manufacturing processes.Must-Have Skills: -MES experience in life sciences manufacturing, specifically with Rockwell FTPS.-Hands-on experience in MES-DCS integration for process automation.-Knowledge of ERP and Data Historian integration with MES.-Hands-on experience in recipe authoring, building block development, and validation.-Strong understanding of pharmaceutical manufacturing, especially biologics. Professional & Technical Skills: -Knowledge of SDLC and pharmaceutical regulations (GMP, GxP, 21 CFR Part 11).-Experience in executing at least one full MES lifecycle project with demonstrated results.-Good communication skills to collaborate with cross-functional teams. Additional Information:-Minimum 10+ years of experience in MES recipe design and deployment in pharmaceutical manufacturing.-This position is based in Hyderabad, Pune, Chennai, Bangalore.-A full-time 15 years of education is required. Qualifications 15 years full time education

Role & responsibilities Profile- In-process QA Minimum Qualification : B Pharma Experience:- Shop Floor for manufacturing and packing. Should be able to conduct IPQA independently. Age: Maximum 35 Years Location: Faridabad

Job description: Providing Line Clearance to the equipment's and areas. Issuance of documents as per procedures. Review of all online documentation activities. To monitor the cGMP at the shop floor periodically. Monitoring process validation activities of various products. Review of GMP records and ensuring compliance for any observations. Responsible for coordinating self-inspection. Assist in deviation, incidence, OOS/ OOT investigations. Awareness in guidance on ICHQ7 Candidates with less than 1 month notice period or immediate joiners will be preferred.

Role & responsibilities : • Responsible for Leading the Quality function and day to day In-process Quality verification with consistent result both in terms of Quality and Quantity to meet daily plant output/customer requirements. • Performing in-process quality inspection for accuracy, specification parameters and workmanship. Develop and implement best quality processes in production • Tabulate and document data relating to products, processes, materials, its qualities, and reliabilities. • Train staff, technicians, and professionals on the aspects of quality control activities. • Troubleshoot and resolve problems relating to quality using quality tools ( analysis of COPQ in order to achieve savings.DMAIC, 8D, 4Q, PDCA etc.) Capture and PDCAP-YY7 • Conducting regular Inspections and Audits to assess product quality and compliance with established standards. • Collaborating with production teams to Identify areas for improvement and develop solutions to address quality Issues. • Ensuring that all quality-related processes comply with local and international regulations and standards. • Providing training and support to production teams to improve their quality control skills and knowledge. • Reviewing customer feedback and using this information to identify areas for improvement. • Support during Customer Intections, QA drafting and approvals etc. Implementing Poka-Yoke wherever possible to prevent quality errors and improve safety level. • Support and lead continuous improvement programs, problem solving and process improvement activities. • Adhere to QMS, other company policies and procedures & Quality Documentation Control. • Strong Technical know-how about the Process flow. KAIZEN & ISO-9001 and 14001,45001 Documentation. • Strong Knowledge about the Corrective Action Plan (8D), Continual Process Improvement. • Shows moral courage, openness and honesty in all dealings. Good communication and interpersonal skill. Skills required: 1.English Communication skills, 2.Good local launguage Communication Skills 3.Good Knowledge in Excel & PPT 4.Team management

02-05 YRS EXPERIENCE, KNOWLEDGE OF IPQA, QUALIFICATION & VALIDATION, AUDIT COMPLIANCE ETC.

Onesource is looking for IPQA executive/ Sr Executives. Pls find the JD as below. Roles and Responsibilities Perform IPQA activities during formulation development, including batch manufacturing process validation. Conduct BMR reviews for injectable products, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to resolve quality issues and implement corrective actions. Maintain accurate records of all QA activities, reports, and documentation.

Role & responsibilities : In process activity in production and packing area, Perform Line clearances activities as per defined instruction in SOP , Continuous monitoring of GMP and cGMP compliance at shop floor, Perform calibration of IPQA instrument on time. Issuance, review and control the change management activities i.e. implementation, post implementation review and proof verification. Preferred candidate profile : Must be B. Pharm Fresher (2024 Batch) Perks and benefits : Stipend : 2,20,000/- LPA

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

As a Officer / Assistant in the Central Stores - Steel department, you will be responsible for managing and overseeing the inventory and warehouse operations. You will be expected to utilize SAP and other IT-related applications to streamline store, dispatch, and logistics processes. You will also be responsible for vendor management and system administration, ensuring smooth operations and timely management of tasks.

Optimus Generics Ltd. is looking for Quality Assurance to join our dynamic team and embark on a rewarding career journey Developing and executing test plans and test cases for software products and applicationsIdentifying, analyzing, and documenting defects and issues found during testingCollaborating with developers to resolve issues and ensure that software meets customer requirementsDeveloping and implementing automated testing frameworks and toolsConducting performance and load testing to evaluate software performance and stability Developing and implementing best practices for testing and quality assuranceCommunicating with stakeholders and team members to report on testing progress and resultsParticipating in the design and development of new software products and applicationsConducting usability testing and providing feedback on user interface design and functionalityParticipating in continuous improvement activities and implementing process improvements to improve testing efficiency and effectiveness Solid understanding of software quality assurance and testing methodologies Strong analytical and problem-solving skills, as well as excellent communication and teamwork skills

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

• Ensure compliance with Stage Gate and Design QA procedures. • Coordination between different stake holders – R&D, QC, QA, RA, Project Management for effective Stage Gate reviews and clearances of Stages. • Review PDRs, Scale up reports including Lab Note books • Participate in designing DOE trials in line with Process • Review Scale up protocols, Exhibit protocols, Process Validation protocols and reports • R&D IPQA • R&D procedural compliances – Qualifications, Calibrations, RLD Management, Stability Management • Responsible for deviation, investigation related to R&D. • Responsible for specification/STP review. Review and clearance of Analytical Method Validations • R&D Documentation Management -Issuance and retrieval • Responsible for clearing Formulation Projects for Scale up and Exhibit batches.

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