515 Ipqa Jobs - Page 15

Develop thorough test plans and document the results and progress Develop in-depth functionality and stability automatic tests that will map customer use cases Research the right set of workloads and benchmarks Develop automated test scenarios and environments for End2End automatic evaluation Collect test evidence measurements to ensure system functionality, stability and scalability Establish automatic measures to assess the accuracy Analyze results to find ways to improve functionality coverage Analyze root causes and identify areas for improvement Collaborate with development teams to drive resolution for issues and improvement Generate test automation summary reports for stakeholders review Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise 3-6 years of test automation development experience 2-4 years of experience in software testing in the workplace 2-4 years experience in Python/Go/Java programming Good English communication skills (written and oral) and be able to work independently and as part of a team. Knowledge of REST technologies is an important advantage. Preferred technical and professional experience Cloud network concepts including software defined networking, virtual private cloud (VPC), network services such as load balancer, firewall, gateway as it fits in cloud network infrastructure Working knowledge of cloud network infrastructure technologies Linux network internals Linux Virtualization technologies relating to network virtualization Kubernetes, Docker Knowledge of bash, go lang, php, awk Working knowledge of Network tools is an important advantage. Knowledge of Windows and Linux operating systems Knowledge of Github and Jira is an advantage. Fast learner and a team player

Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Review of BMR and other production and quality control related documents. Major experience in API IPQA activities (like: Plant rounding & monitoring). Preparation of APQR.

. Prepare and review the Product Quality Review. . Investigation related to Deviation, Queries received from the customers and regulatory department related to Product Quality Review. . Adherence and compliance to cGMP requirements. Required Candidate profile Applicant must be Pharmacy graduate / post graduate with experience of IPQA Activity in Oral Liquid / Tablets/ Capsule/Dry Syrup.

Candidate should have Exp. in pharma API & Intermediate. Handling of OOS/OOTs Review of Analytic data received from QC. Handling Audits and conducting internal Audits.

Dear All, We are conducting Walk-In Interview on 13th June 2025(Friday) for Quality Assurance and Quality Control( Formulations ) departments. Quality Assurance: AQA - 6-8 Years of experience in Analytical QA IPQA - 2-4 Years of experience in Line Clearance activities for Production, Warehouse and Dispensing of Raw Materials Quality Control: IPFP - 4-5 Years of experience in HPLC, GC, UV, Dissolution and RS. Stability - 4-6 Years of experience in Dissolution, GC, UV and Sample management Raw Materials - 2-3 Years of experience in sampling of Raw and Packing materials Analytical Method Validations - 3-5 Years of experience in Method validations, HPLC and Dissolution instruments Microbiology - 2-3 Years of experience in Environmental monitoring, Culture media preparation and MLT testing Note: Candidates who are unable to attend the interview, can share their resumes to raghuveera.vutla@aizant.com Venue Aizant Drug Research Solutions Pvt Ltd, Sy.No. 172 & 173, Apparel Park Road, Dulapally, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District-500100

Role & responsibilities - QA (IPQA & AQA) 1. Personal Hygiene check-up of the staff and employees 2. Maintaining Quality Aspects and issuing Line clearance in Production department. 3. Controlling Document flow and completion of BMR and BPR in both the above areas 4. Checking Log books for the machineries in the above said areas 5. Issue and Receiving of Stereos/Computer generated OPD for packing 6. Ensuring In process controls as per Procedure. 7. Ensuring process is validated and carried out as per batch record instructions. 8. Ensuring process is validated and carried out as per batch record instructions. 9. Ensuring status labels/labeling of containers, equipments and materials. 10. Ensuring online documentation and timely entries of all operations/activities. 11. To monitor and ensure physical parameters such as Temperature, RH & Differential pressure. 12. Monitoring of personnel movement and clean room behaviour in process area. 13. Collection of stability and control samples 14. Collection of Finished product samples 15. Machine parameter verification 16. Verification of loads as per validated load pattern in Autoclave 17. Any other assignment given by the Quality assurance manager from time to time. only Candidates with Pharma experience/ Immediate or within 30 days joiners are requested to apply. Perks and benefits As per company standard

DEPARTMENTS: QA, TECH TRANSFER, SAFETY (EHS), PRODUCTION & PACKING WORK LOCATION: Vemgal, Bengalore JOB DESCRIPTION: PRODUCTION Experience: (01 07 Years) •Granulation, Compression, Coating, Capsule filling PACKING Experience: (01 07 Years) •Bottle Packing (Primary & Secondary), Blister Packing (Primary & Secondary) QA Experience: (03 08 Years) •IPQA, Validation & QMS Safety Experience: (01- 05 Years) •EHS, Risk Assessment, ETP, STP Tech Transfer Experience: (01- 05 Years) •Technology Transfer, QUALIFICATIONS : ITI/ B.Sc/ Diploma/ B. Pharm/ M.Sc with relevant experience DESIGNATIONS: Jr Operator/ Operator/ Jr. Officer/ Officer/ Jr Executive/ Executive• INTERVIEW VENUE: Hotel: RK Gardenia, No. 5/1 Anekla Road. Opposite Surya City P-1, Chandrapur, Bangalore- 560099 CONTACT INFO: E-mail: Chandrakanth.k@hetero.com & Contact : 9100163871 for further info

Job Area: Finance & Accounting Group, Finance & Accounting Group > Internal Audit General Summary: Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus. Minimum Qualifications: Bachelor's degree. 3+ years of Finance, Accounting, or related work experience. *Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview Qualcomm is a company of inventors that unlocked 5G - ushering in an age of rapid acceleration in connectivity and new possibilities that will transform industries, create jobs, and enrich lives. But this is just the beginning. It takes inventive minds with diverse skills, backgrounds, and cultures to transform 5Gs potential into world-changing technologies and products. This is the Invention Age - and this is where you come in. This is a unique opportunity to join Qualcomms finance and accounting organization based in Hyderabad in the Corporate Internal Audit & Advisory Services (IA & AS) team. The department focuses on assisting the Audit Committee and management teams in the improvement of processes that manage risks related to achieving Qualcomms business objectives. Using Qualcomms risk-based audit methodology, the senior auditor will assist in the execution of internal audits. Specifically, the responsibilities include: Providing U.S. based time zone coverage as needed (up to 50% of time) Supporting the creation of initial planning memos and process flowcharts Identifying and assessing initial risks and control activities Designing audit procedures to evaluate control effectiveness Performing audit testing, identifying deviations from expected control activities, and effectively communicating observations to the audit team Leveraging data analytics throughout the audit process where feasible Staying abreast of changes in business and industry to assess impacts on the companys risk profile Contributing to the development of new concepts, techniques, and making continuous process improvements for the overall IA team All Qualcomm employees are expected to actively support diversity in their teams, and in the Company. Minimum Qualifications Three to Five years of relevant experience in internal auditing, external auditing, or SOX compliance within a global public company (preferably in the high-tech industry), Big 4/mid-tier accounting firm or other fast-paced corporate setting Fluent English; multi-lingual capability is a plus Preferred Qualifications Successful candidate will possess the following characteristics: As feasible, ability to travel (infrequently) to Qualcomms domestic and international locations (e.g., U.S., Europe) Semiconductor business experience or familiarity Strong communication (oral and written) and presentation skills Fast learner with strong interpersonal, organization, analytical, critical thinking, and problem-solving skills Ability to work in a flexible and non-hierarchical team environment Willingness to get things done and take responsibility Ability to recognize and apply a sense of urgency, when necessary Comfortable with ambiguity Positive attitude, professional maturity, good work ethic Ability to work independently, handle multiple projects simultaneously and multi-task to meet deadlines with high-quality deliverables Keywords controls, risk assessment, risks, internal audit, SOX Educational Bachelors degree in accounting, Finance, Business Administration, or related field. CPA, CA, CIA, CFE, or other credentials, a plus.

Sr. Executive AM- Hot Refining: CMR GreenTechnologies Limited CMR Group is India's largest producer ofAluminium and zinc die-casting alloys. With 13 state-of-the-art manufacturingplants across the country, CMR has become the preferred supplier for many ofIndias largest automotive industry leaders. Since its inception in 2006, CMRhas consistently outpaced competition by focusing on delivering superior valueto its stakeholders. This value is driven by a strong commitment to technicaladvancements, quality enhancement, sustainability, and people-centric practices.We believe in an " Employee First " philosophy, ensuring that our people are at the core of our success. Our dedication tofostering an enriching work environment is reflected in our recognition asthe 'Most Preferred Place for Women to Work' and as one ofthe Top 25 Mid-Sized Indias Best Workplaces in Manufacturing for 2025 by GreatPlace to Work. As CMRcontinues to chart its growth trajectory, we remain committed to innovation andexcellence. We are always looking for enthusiastic and dynamic individuals tojoin our team and contribute to our continued success. Position : FLO- Hot Refining Location: Tirupati , Vallam , Orissa Job Band : A Designation : Sr.Executive/AM. No.of Posts : 2 Reporting to : Area Head - Hot Refining Qualification: Essential Candidateshould have full time degree or Diploma in Mechanical / Electrical / Metallurgyor a related field form any reputed institution. Desirable Degree/Diploma/Certification Course in Operation / General Management. Experience: Essential 3 to 5 years ofexperience in a hot refining or similar role within the refining ormanufacturing industry. Desired Strongunderstanding of refining processes and technology. Experiencewith process optimization and quality control in a refining environment. Excellentproblem-solving skills and the ability to troubleshoot complex technicalissues. Knowledgeof industry standards for refinery operations. Job Profile: Responsiblefor ensuring minimal deviation from " Process Monitoring Sheet " Overseehot refining operations of operators such as - Charging schedule, Fluxquantity, Alloying composition and addition of virgin alloy material etc.across Furnaces. Ensuresshift cost control, production, melt loss, dross production, recovery andquality targets Responsiblefor Quality report sign of basis spectrometry and visual checks, as well as ERPbooking Respondsto issue escalations during shift Coordinateswith maintenance to ensure availability of machine/equipments and smoothoperations during the shift Controlcorrection Ingotquality control and also control weight variation of ingots. Controlplant pollution Followall process parameter during process. CoreCompetencies: Qualitystandards Effectivecommunication Knowledgesharing and learning. ResultOriented. PreferredSkill :- Experiencewith implementing new technologies in a refinery setting. Knowledgeof environmental regulations and sustainability practices in refining. General Age-27- 30 years. CTC 3LPA to 6.5 LPA approx. Candidateshould not be frequent job changer. NoticePeriod- Joining period Max 30 Days. We can buy notice period, if required Location: Vallam: G 108/2, SIPCOT Industrial Park, Vallam Vadagal, Kanchipuram District, Vallam, Tamil Nadu 631604 Tirupati: Survey No. 429-434, APIIC Industrial Park, Chinthalapalem Village, Yerpedu Mandal, Tirupati District, Andhra Pradesh 517619 Orissa: Plant Survey No. - 2020-2027, 1991-1993, Village Derba, Tehsil Rengali, Dt. Sambalpur, Odisha 768212

Role & responsibilities 1) To perform line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labeling and packing 2) To perform Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. 3) To issue and control of SOPs, BMRs, BPRs, BCRs and also finished product label/product container seals /sealing of the containers as the part of IPQA activities. Preferred candidate profile

To involve from start and investigate level 2 & 3 incidents, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To Involve in valid OOS and other cases as relevant, by working closely with site CFT and operating people to arrive at proper Root cause, CA and PA and in report writing. To review level 1B incidents and give feedback for improvement. To periodically trend level 1A incidents and highlight/escalate key observations. To review any other referred reports associated with incidents/events in association with sites. To possess high level of integrity to have unbiased, independent and objective closure of incidents and maintain high level of confidentiality and have the tenacity to get to the root cause. To use Rubrics template for investigation report writing. To provide appropriate support to site in preparing for or during regulatory inspection for investigations. Qualification B Pharmacy Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

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.

Role & responsibilities Aurobindo Pharma Ltd. Unit IV (Naidupeta, Tirupati Dist., Andhra Pradesh) Open Functions: Quality Assurance (Market Complaints / QMS / Validation / IPQA) Quality Control (GMP / GC / LCMS / HPLC) 3 Experience Required: 2 7 years (pharmaceutical manufacturing) Job Titles & Grades: Executive / Sr. Executive (based on experience) Job Description: Quality Assurance Key Scope • Handle Market Complaint investigations, trend analysis and regulatory responses • Maintain site QMS: Deviations, CAPA, Change Control, Audit readiness • Execute and review Equipment / Process / Cleaning Validation documentation • Perform IPQA activities: line clearance, in-process checks, batch record review • Conduct GMP & Data-Integrity training for shop-floor teams Quality Control Key Scope • Routine & stability testing of RM / IP / FP samples on HPLC, GC, LCMS, UV, etc. • Prepare/standardise analytical methods, calibration & instrument qualification (IQ/OQ/PQ) • Adhere to GDP, ALCOA+ and cGMP guidelines; ensure timely LIMS/SAP data entry • Investigate OOS/OOT results and implement effective CAPA • Support regulatory, customer and internal audits Common Requirements: • Qualification: B.Pharm / M.Pharm / B.Sc. / M.Sc. (Chemistry or related) • Sound knowledge of current GMP guidelines (US-FDA, MHRA, EU, WHO) • Good documentation, investigation and communication skills • Willingness to work in shifts and collaborate with cross-functional teams How to Apply • Send you updated resume : naidupetahr@aurobindo.com • WhatsApp : 9851444337

Retrival& Issuance of documentation GDP CGMP Control Documents Dispatch verification Batch Manufacturing

Roles and Responsibilities Conduct quality audits, inspections, and reviews to ensure compliance with industry standards and company policies. Identify areas for improvement through root cause analysis (RCA) and implement corrective actions using tools like Poka Yoke, Capa, and Kaizen. Develop and maintain documentation related to quality control processes, including procedures, checklists, and reports. Collaborate with cross-functional teams to resolve issues related to product defects or non-conformities. Desired Candidate Profile 3-8 years of experience in a manufacturing environment with expertise in 7QC, 5S, IPQA/IPQC, IATF 16949:2016 certification. Strong understanding of QC tools such as Vernier caliper, Micrometer, Height gauge; rejection analysis; reject handling process. Proficiency in MS Office applications for document preparation and record-keeping. Regards Aadhya Agrawal 8439753001

Aster Medcity 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.

Job Title: Officer/Sr Officer/Executive Logistics Job Location: Head Office, Thaltej, Ahmedabad Responsibilities: Track shipments of commercial and promotional pharmaceutical products across various transport and courier partners Ensure timely collection and verification of Proof of Delivery (POD) for all dispatches and maintain organized records for audit and compliance purposes Identify shipment-related issues such as delays, damages, cold chain breaches, or documentation discrepancies Collaborate with Logistics Service Providers (LSPs), including third-party transporters and courier agencies, to resolve delivery issues promptly Coordinate with internal departments such as Sales, Regulatory, Warehouse, and Supply Planning teams to ensure smooth order execution and delivery Maintain shipment tracking reports, POD logs, and performance dashboards as per SOPs Ensure adherence to Good Distribution Practices (GDP) and applicable pharma logistics regulations Support product traceability, recalls, or market returns by maintaining accurate and retrievable logistics records Experience: Minimum 6 months to 3 years in SCM department with strong knowledge of Microsoft Excel Show more Show less

Should have minimum 2-6 years of experience in IPQA (Injectable) or Analytical QA (OSD/Injectable)

Walk-in Drive @ Chennai on 15th June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles across our Manufacturing facilities in Chennai & Pondicherry. Venue: Days Hotel by Wyndham Chennai OMR, 245/1, Rajiv Gandhi Salai, Chennai, Padur, Tamil Nadu-603103 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Chennai/Pondicherry Key Skills: HPLC, GC, UV, IR, KF, FTIR, Dissolution, LIMS, GLP Department: Quality Assurance Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: IPQA, QMS, BMR Review, BPR Review, Line Clearance, Change Control, Deviation, CAPA Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Chennai Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Bottle Packing Machines Department: Engineering Utility & Instrumentation Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Chennai Key Skills: Utility, Water System, HVAC, Chillers, AHU, Air Compressors, Cooling Tower, DG, LT & HT Panel, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

1.0 Key or Primary Responsibility: Role & responsibilities 1.1 Line clearance for dispensing raw materials and manufacturing activities 1.2 Document issuance, distribution, retrieval, retention, and management 1.3 In process quality check for drug substance packing process 1.4 Distribution of SOPs, controlled copies of required documents to respective departments. 1.5 Coordination and timely completion of work as per management instruction. 1.6 To make documents controlled, uncontrolled, issuance, obsolete, execution and reference copies whenever required and update the tracking sheets as well. 1.7 To retrieve the executed documents from all departments and filing properly in QA document cell. 1.8 To prepare lists of documents retrieved from all departments and documents available in QA document. 1.9 Stamp management and maintaining properly under lock and key. 1.10 To arrange and label the files in QA document cell. 1.11 Preparation, coordination, and execution of vendor audit. 2.0 Secondary Responsibility: 2.1 Supporting the regulatory department for licensing activities 2.2 Issuance and retrieval of daily and monthly documents. 2.3 Controlling & distribution of the new SOPs to the respective departments, retrieving and destruction of the old-controlled copies of documents/ SOP's 2.4 Responsible for undergoing training in BGL policies and following BGL policies. Preferred candidate profile 3.0 Knowledge and skill set: 3.1 Effective communication skills and Good at Microsoft document editing 3.2 Ability to manage cross functional departments 3.3 Good in handling documentation

1. Handling the Customer independently - Customer Quality care & Product Quality 2. Handling the IPQA roll Box build area ( Good Knowledge in SMT,TH process) 3. Desision making accrding to the standards : IPC A 610. 4. Facing the External audits( ISO TL9000/ Customer audits) 5. Creating the Control plan, FMEA, Wrok insruction. 6. Manufacturing Process audit,ESD audit to Comply to QMS / Product requirements 7. Data collection, Trending, analysis and drive improvements 8. Statistical tools (8D,7QC, WHY-WHY analysis, Fault tree / factor analysis, Risk assessment). 9. Closely Coordinate & Monitor the NCMR & RMA process 10.Daily monitor the Yield trends & Performances. 11.Drive CFT for the internal and Customer failures 12 Review customer documents, drawings and specifications to incorporate in internal procedure 13. To prepare the Customer Weekly/Monthly Reports 14. Good English communication is MUST

Job Description and Responsibilities Reviewing packaging activity at CMO site Handling of Computerized Training Management system related activities Handling of Change Request Forms through Computerized software Preparation and Review of Certificate of Analysis (CoA) Analytical Result entries to SAP batch data Maintenance of SOPs and Internal guidelines in SAP Handling of GMP/ MIA certificate availability activity Managing various Quality Assurance documents and notifications Preparation of Report for QA activities Primary Skills (essential) 4 - 5 years experience in Quality Assurance (preferably Pharmaceuticals)/ IPQA (Packaging) Experience in managing various Quality Assurance documents and notifications Proficient in MS Office Experience of working in ERP / SAP and computerized systems like Track wise/ DMS would be an added advantage Good English communication skills (both verbal & written) Good Interpersonal Skills Ability to work in team and flexibility to adapt to change Education Bachelors/ Masters degree in Pharmacy / Science from a reputed College / University

> Ensure that sample checks are conducted at all production personnel. > Perform quality analysis and records result for raw materials,semi finished goods,finished goods and packing materials. > Inform the quality issue of raw matrials.packaging materials to the concerned department and Head QA & QC. > Provide quality improvement feedback on semi-finished goods and finished goods to operation. > Documents all inspection,testing result amd statistical reports for future reference > Prepare samples with certificate of analysis & dispatch to marketing department,registration department for export & domestic market. > Provide feedback of counter sample analysis of the product with certificate of analysis to marketing deoartment legal department -sample drawn by agriculture department. > Handle /attend customer complains regarding product

Ensure compliance to cGMP for all operational activities. Monitor the formulated products against stipulated conditions mentioned in the Batch production record. Conduct certificate of batch production records for compliance and stage wise completion. Conduct line clearance during manufacturing and the packing activities. Conduct sampling activities during the manufacturing and the packing activities. Conduct qualification, PPV, PM and calibration of in-process instruments as per schedule. Swab and Rinse sampling activity for cleaning validation and verification studies. Initiate Deviation, Change Control and Investigations. Provide support to conduct investigations related to deviation, CAPA, OOS, OOT, and Market complaint handling. Issuance of Batch production records. Review Verification of Bin for Documents / Labels Destruction as per SOP.