7 Qms Documents Jobs

Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.

Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity Work experience in Pharma or IT Sector will be desirable Roles & Responsibilities Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites. To liaise with Site IT , Business SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities. To work along with Business, IT, QeC & Project Manager to ensure project timelines are met. Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. Competencies Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must) Experience of working with Global Pharma Cross functional Sites QC, QA, Manufacturing, IT, SAP etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less

Job Title - Executive Quality Assurance Department : Corporate QA Job Location - Kandivali - West, Mumbai Qualification : B Pharm / M Pharm Experience : 5 - 8 years Roles & Reponsibilities: Issuance of activity record such as calibration record sheets, log books and lab note books etc. Issuance and retrieval of SOPs applicable for AMV laboratory. Review and approval of QMS documents such as laboratory deviations, incidents, CAPA etc. Review and approval of SOPs applicable for AMV laboratory. Responsible for QA oversight on operations of AMV laboratory. On-line review of data entries (paper and electronic) as a part of a Data Reliability Review. Review and approval of Analytical method development dockets. Review of audit trail and electronic data of Analytical method validation laboratory instruments. Any other job assigned by head of the department. Show more Show less

The Production Packing Assistant Manager/Manager is responsible for overseeing day-to-day production planning and execution to ensure requirements are met. You will be in charge of supervising and evaluating the performance of production personnel, organizing workflow to meet specifications and deadlines, and distributing staff/workers according to production planning. Additionally, you will review, approve, and implement departmental SOPs in accordance with current guidelines. You will also be responsible for monitoring online documentation such as BMRs, BPRs, log books, and other relevant documents. Monitoring the stage-wise process for product yield, reviewing QMS documents, qualification protocols, and other online documents for CAPA implementation will also be part of your duties. The ideal candidate should have knowledge of aseptic area practices, vial/ampoule filling and sealing, LYO products, regulatory audits, and packing and visual activities to ensure targets are achieved for packing, labeling, and visuals. Experience with cartridge printing, specifically Track & Trace, is also required for this role.,

As Manager 2 in the Corporate Quality department at SUN Pharma, you will be responsible for overseeing the quality aspects of contract manufacturing organizations (CMOs) involved in manufacturing site transfer products for the US market. Your primary focus will be to ensure compliance with SUN Pharma Quality and Compliance Standards as well as global regulatory requirements. Your essential job functions will include monitoring and overseeing activities at CMO sites to ensure adherence to SUN Pharma standards and regulatory guidance. You will conduct regular oversight visits, prepare visit reports, and serve as the main point of contact for coordination between SUN site, commercial team, corporate quality audit, and CMO site on manufacturing and technical matters. Additionally, you will be involved in authoring and reviewing quality agreements, ensuring the use of qualified service providers, participating in process validation batches, reviewing quality system documents, conducting visits based on market complaints/recalls/CAPA, reviewing batch records, stability data, and analytical reports, as well as preparing and reviewing SOPs. Your role will also include participation in the initial evaluation of CMOs, supporting regulatory audits at CMO sites, engaging in critical investigations, initiating QMS documents, preparing for regulatory agency inspections, participating in product release site audits, maintaining audit-related documents, preparing monthly reports, staying updated on regulations through training, and following Corporate Quality Policies/Global Quality Standards and Regulatory Guidelines. To be successful in this role, you should have an M.Sc./B.Pharm/M.Pharm or equivalent degree along with a total of 10 years of industrial experience and knowledge. You will also be expected to participate in and execute project work assigned by your reporting authority. If you are looking for a challenging opportunity to ensure quality compliance in contract manufacturing organizations and contribute to the overall quality standards of SUN Pharma, this role is ideal for you. Join us in our mission to maintain high-quality standards and regulatory compliance in the pharmaceutical industry.,

You are invited to attend a walk-in interview at Zydus Biologics, Ahmedabad for the position of Warehouse Executive / FTE. As an Executive, you should possess an M.Sc./M. Com/ B.Sc. degree with 2-7 years of experience in GMP system. It is essential to have the ability to write QMS documents and demonstrate excellent knowledge of SAP, including proficiency in all T-Codes for tasks such as making GRN invoice, STO, and FG dispatches. You will be responsible for performing equipment validation and performance verification activities for the cell bank storage system, deep freezers, and temperature monitoring in the warehouse area. A solid understanding and experience in material management for raw material, consumable, API (DS), and drug product are required for this role. As a Fix Term Employee, candidates should have an HSC/ ITI qualification with 1-3 years of experience in handling and moving materials according to SOP. Responsibilities include material receiving, verification, documentation, dispensing/reconciliation of RMPM, and temperature and RH monitoring. The ability to perform cleaning activities is also essential for this position. If you are attending the interview, please remember to bring your latest resume, salary slips, CTC breakup, and all original academic documents. This opportunity is based in Ahmedabad, and the interview is scheduled for 12th July 2025 (Saturday) from 10:00 am to 3:00 pm at Zydus Biologics, Biotech Park, Opp. Ramdev Masala, Changodar Road, Ahmedabad-382213.,

The ideal candidate for this position should be prepared to work in rotational shifts. You should have practical experience working with API manufacturing equipment and be adept at troubleshooting any issues that may arise. A good understanding of clean room activities is essential for this role. It is important to strictly adhere to data integrity and safety protocols. Basic knowledge of Quality Management System (QMS) documents is also required. You should be transparent in your work approach, take ownership of assigned tasks, and communicate any relevant information to the supervisor in a timely manner.,