27 Apqr Jobs

Implement & maintain quality systems in compliance with cGMP & regulatory norms.batch review, product release,change control,QA documentation,audits, manage deviations, CAPA,OOS investigations.quality metrics & APQR & regulatory inspection readiness.

As a Validation Specialist at Piramal Pharma Solutions, your primary responsibility will involve preparing and updating various validation documents to ensure compliance with regulatory requirements. This includes developing Validation Master Plans (VMP), Process Validation protocols, Computer System Validation protocols, and reports. You will also be responsible for creating product matrices, Cleaning Validation/Verification protocols, qualification/requalification protocols for equipment/instruments, utilities, and facilities, as well as area validation protocols and reports. In addition to validation activities, you will be involved in quality risk assessments, review of calibration certificates, issuance and archival of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), preparation of Annual Product Quality Review (APQR), line clearance for manufacturing, packing, and dispensing activities, sampling of bulk and finished goods, and review of production records. Furthermore, you will play a key role in managing change controls, deviations, and CAPA (Corrective and Preventive Actions), conducting complaint handling, updating departmental SOPs, providing training as per schedule, coordinating training programs with HR, and ensuring documentation management as per SOP. You will also be responsible for providing necessary documents/data to meet internal and external quality, environmental, health, and safety requirements. Moreover, you will be involved in compliance monitoring through self-inspection programs, audit compliance coordination, preparation of responses to audit reports, and execution of food/dietary supplements regulations for export markets. You will also oversee the implementation of sanitation programs, adherence to EHS norms, and various corporate initiatives. Piramal Group values equal employment opportunity, ensuring that all applicants and employees are treated fairly based on merit, qualifications, skills, and performance. As part of a globally integrated network of facilities, Piramal Pharma Solutions offers a wide range of services across the drug life cycle, making it a trusted partner for innovators and generic companies worldwide.,

Implement and maintain QMS per GMP. Conduct audits, vendor qualification, and quality reviews. Approve SOPs, BMRs, BPRs, specs, change controls, APQRs. Investigate OOS, OOT, complaints, oversee CAPA, and ensure compliance across all departments. Required Candidate profile QMS Implementation | cGMP Compliance | Internal & External Audits | SOP/BMR Review | Change Control | CAPA | APQR | Risk Assessment | Vendor Qualification | Regulatory Compliance | Root Cause Analyse

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,

Job Title: Executive - Senior Officer - Quality Assurance Department: Quality Assurance Location: Vadodara Experience: 4 6 years Qualification: B.Pharm / M.Pharm Job Summary: The Executive Quality Assurance is responsible for ensuring compliance with cGMP standards through effective execution of Validation, Annual Product Quality Review (APQR), and Quality Management System (QMS) activities. The role involves coordination with cross-functional departments, documentation management, and continuous quality improvement. Key Responsibilities: 1. Validation: Prepare, review, and execute validation protocols and reports (Process, Cleaning, Equipment, HVAC, Utilities, etc.). Ensure timely qualification and requalification activities. Review and evaluate validation data and ensure compliance with regulatory and internal quality standards. Coordinate with production, engineering, and QC for smooth execution of validation activities. Maintain validation master plan and validation documentation repository. 2. Annual Product Quality Review (APQR): Coordinate collection and review of data from production, QC, and other departments for APQR. Prepare and compile APQR reports as per regulatory guidelines and internal SOPs. Identify trends, deviations, and opportunities for process improvements based on APQR findings. Ensure timely completion and approval of APQRs. 3. Quality Management System (QMS): Participate in implementation and maintenance of QMS elements (Change Control, Deviations, CAPA, Risk Management, Document Control, etc.). Ensure timely closure of QMS records and proper documentation. Support internal and external audits, including regulatory inspections. Contribute to continual improvement initiatives and ensure regulatory compliance. Key Competencies: Sound understanding of cGMP, ICH, 21CFR, WHO, and regulatory requirements. Strong analytical, documentation, and communication skills. Proficient in handling QMS software (e.g., TrackWise, Veeva, or similar tools). Ability to work independently and as part of a team. Attention to detail and quality-focused mindset. Preferred Skills: Experience in pharmaceutical manufacturing environment (oral solid dosage). Exposure to regulatory audits (USFDA, MHRA, EU, etc.). Knowledge of data integrity practices and electronic documentation systems.

Opening with an leading Pharma Company. Role & responsibilities : Continuous process Monitoring Batch Release of Finished product Collection of Sample ie in-process, Finished Product , Control, Stability and Tendor Knowledge of Collection of Validation samples i.e process validation, cleaning and hold time validation. Knowledge of review of Master and executed MFR/BMR and MPR/BPR Adequate knowledge of Inprocess checks of Tablet ,Capsule ,Liquid and Ointment. Adequate knowledge of Shop floor related Non-compliance ,its root cause and compliance. Adequate knowledge of calibration of instruments ie weighing balance , friabilator, DT apparatus, hardness tester, Vernier calliper, Moisture analyzer, leak test apparatus and Ph meter etc. Interested candidates shared resume on snehal@topgearconsultants.com

Job Responsibilities Sr. Executive Quality Assurance Headquarter: New Delhi/Faridabad Purpose of the Position :- To ensure document & data control activities are performed as per approved QMS. Job Responsibilities: 1. Responsible for document and data control activities related to QMS. 2. Responsible to do issuance of all prepared documents and retrieve all superseded documents. 3. Responsible to update all master document list as per requirement. 4. Responsible to update document tracking system. 5. Responsible to maintain all QA logbooks. 6. Responsible to do timely issuance of controlled logbooks, formats and other required documents to all departments as per requirement. 7. Responsible to maintain record of external origin documents. 8. Responsible to develop new product artwork as per requirement. 9. Responsible to revise existing product artwork as per requirement. 10. Responsible to maintain records of artwork and shade cards. 11. Responsible to review online filled BMR, BPR and all other batch related records. 12. Responsible to prepare & review MFRs of Raw material, In-process Material and Finished Products. 13. Responsible to prepare & review SOPs of QMS Processes. 14. Responsible to prepare & review APQRs. 15. Responsible to review documents related to OOS, Non Conformity, Deviation, CAR & Change control. 16. Responsible to prepare Quality Manual, Validation Master Plan and Site Master File. 17. Functional Reporting shall be as per departmental organogram. 18. Any other task assigned by the Reporting Manager. The responsibilities may be reviewed/added as per company requirements from time to time.

Immediate joiners are preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com 1.To review and implement Quality Management System for cGMP compliance at site. 2.To review and approve of product design. 3.To review and approval of production and quality control documentation for compliance with GMP and GLP requirements. 4.To Handle Caliber BRM, QAMS, DMS, Nichelon 5 CMS, E-logbook, E-schedule, Microsoft Dynamic, NCR 5.To review and approve SOPs, Validation Protocols, Master Batch Production Records and other related documents at site. 6.To review and approve Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP. 7.Approval signatory for all SOPs, Master Batch Records, Qualification, Validation, documents of Analytical and Manufacturing equipment, Specifications, Change Control, OOS investigations and other investigations, Stability Protocols, and other Master Documents. 8.Vendor Assessment. 9.Handling of OOS. 10Process validation and equipment cleaning validation. 11.To review batch production Records and Analytical documents, to assure that the batch has been manufactured and tested as per laid down procedure / specification. Deviation if any, are recorded, investigated, documented and authorized. 12.To export certification for batches intended for exports. 13.To release (approval or rejection) the batch manufactured at site. 14.To monitor qualification, validation and requalification activity at site. 15.To trend the data and analyses the trend. 16.To Prepare and approve Annual Product Quality Review for drug substance / drug product quality, Recommend the area of improvement, as applicable. 17. To investigate market compliant. Review response. 18.Handling of product recall. 19.To review Product License Application and support Regulatory department for obtaining the product license from the local Regulatory Authority. 20.To review and submit the data / information to Regulatory Affairs for preparation of DMF/dossiers/application for registration of the product with Regulatory Authority of the countries, intended to market the product. 21.To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit.

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

1. Managing the entire QA and QC activities in the plant. 2. Monitoring, Documentation and implementation of process development. 3. Making sure that there is satiability data to support retest or expiry dates and storage conditions on APIs and /or intermediates where appropriate; and performing product quality reviews. 4. Reviewing completed batch production and laboratory control records of critical process steps before release of the API intermediated for distribution 5. Making sure that critical deviations are investigated and resolved. 6. Approving all specifications and master production instructions, Test methods, Qualifications. 7. Approving all procedures impacting the quality of intermediates or APIs. 8. Making sure that quality related complaints are investigated and resolved. 9. Making sure that materials are appropriately tested and the results are reported. 10. Ensuring Technology Transfer from Pilot Plant Level to Plant Level implementation. 11. Ensure the preparation of DMF and other related information at all the Units. 12. Ensuring Quality management system is followed at the site. 13. Responsible for all the Internal and External Quality Audit and EHS Aspects. 14. Handling regulatory details under guidance of Director(Works) 15. Approving intermediate and API contract manufacturers. 16. Approving changes that potentially impact intermediate or API quality. 17. Ensuring GMP training is providing to all the employees in the site. 18. Ensuring quality culture in the organization on QMS EMS.

Must have experience of Vaccine/Biological Industry IPQA activity in Production BMR Review/ Line clearance Process Validation Media fill Validation Gowning Qualification/Visual inspector Qualification Trend/APQR preparation Investigation & Evaluation Dossier document compilation Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Technical Documentation Must have documentation experience in COA, MSDS, VQ Filings, APQR, MOA, DMF, Stability data

Key Responsibilities: Lead and manage regulatory activities and documentation (individually and through a team). Ensure compliance with South Africa/country-specific guidelines. Review and peer-review regulatory submissions (electronic & non-electronic). Track and oversee project timelines and regulatory deliverables. Liaise with internal/external stakeholders to ensure timely documentation. Prepare/review APQR summary reports and implementation notifications. Stay updated on changing regulatory legislation. Guide and train internal teams on regulatory requirements. Ideal Candidate Profile: 6-9 years of experience in Regulatory Affairs. Strong knowledge of South African and/or international regulatory guidelines. Background in Pharmacy, Life Sciences, or related field. Excellent documentation, analytical, and communication skills. Experience in handling submissions and quality checks under tight deadlines.

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

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

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

3+ years of hands-on CMC experience required with JMP for statistical analysis, including DoE(Design of experiment), statistical approaches: PCA, and PLS. Strong understanding of QbD, PQR, and regulatory guidelines (ICH/FDA) required. Proficiency in SAS/R programming is essential Software: Minitab and JMP

Role & responsibilities In-Process Monitoring : Monitor and evaluate the manufacturing or production processes in real-time to ensure compliance with quality standards and specifications. Sampling & Inspections : Conduct regular inspections, sampling, and testing of raw materials, in-process goods, and finished products to ensure quality control is maintained at every stage. Documentation & Reporting : Maintain accurate records of in-process quality checks, test results, and production data. Report any deviations, non-conformities, or issues to the production team and management. Training & Support : Provide guidance and training to production staff on quality standards, best practices, and regulatory requirements. Compliance : Ensure that the production process meets relevant industry standards and regulatory guidelines, such as FDA, ISO, or others as required. Preferred candidate profile Experience with SAP or similar ERP software systems for quality documentation and process management. Knowledge of in-process quality control techniques, statistical methods, and testing protocols. Interested Candidates can share their resumes at Anee.Silas@otsukapharma.in

Job Description 1 Master & Control of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records to concern departments. 2 Issuance of all documents like SOPs, BMR, Specification & MOA, logbooks ,calibration records to concern departments 3 Preparation of all documents like SOPs, BMR, Specification & MOA, logbooks, calibration records of concern departments 4 Reviewing of HPTLC, TLC, GC reports, peaks, graphs etc 5 Checking & signing of BMR of Liquid syrup, Tablets & Mother tincture section. 6 Receipt & storage of executed documents like BMR, Analytical logbooks, calibration records etc. 7 Receipt & storage of control samples of finished product, raw material etc. 8 Receipt, storage & destruction of superseded SOPs. 9 Preparation of process validation protocol & Report. 10 Receipt & storage of executed validation protocol & Report 11 Receipt & storage of executed Qualification documents of equipment & instruments 12 Stability studies documentation with help of Quality control. 13 Preparation & Revision of SOPs of Quality Assurance department. 14 Compliance and preparation of Audit Report. 15 Maintenance of control sample room & Documentation room. 16 Training of sub ordinates & evaluation. 17 Preparation of Training schedule and its implementation and monitoring. 18 Identification of training needs to internal/ external to the sub ordinates. 19 Compliance of Audit Report from Government authorities (FDA). 20 Any other activity assigned by the management.

Role & responsibilities The individual should be documenting Annual Product Quality Review (APQR): Collection of process and quality data for all products. The individual is capable for management of Retain Samples: Storage, maintain, visual inspection & destruction of Retain samples of all FG samples. Management of central document room/Documents: Issuance, Retrieval, Destruction & Control of all the GMP documents (eg: facility documents, Batch records, Protocols, Reports, etc.) Key competencies Skill Required/ Tools/ Software: The individual is responsible to work in compliant with Good Documentation Practice (GDP) and current Good Manufacturing Practice (cGMP). Interpersonal Skill: The individual must have good communication skill with team, team-work capabilities, patience to work under pressure. Digital Skills: Effectively use MS tools, i.e., Word, Excel, PowerPoint, in day-to-day operations. If required, need to operate company software.

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Develop & update SOPs, ensure compliance, prepare MSDS/specs, review BMRs, check COAs/labels, maintain documentation, conduct training, perform audits, and support corrective actions to uphold quality standards across operations.

Desired Candidate Profile 2-5 years of experience in Quality Assurance & Compliance role in API manufacturing industry. MS/M.Sc(Science) degree in Chemistry Strong understanding of GMP & Regulatory Compliance, Document Control & SOP Management, APQR, CAPA & Market Complaint Management.

Preparation of Technical documents like below: COA/ Certificate of Analysis Specifications/ TDS Method of Analysis Stability Data DMF/ Drug Master File Declarations Preparation of Vendor Questionnaire Customer response for technical queries