18 Qms Documents Jobs

About Intas Recruitment Fraud Disclaimer: Intas Pharmaceuticals does not request or accept any fees during recruitment. If someone asks for payment on our behalf, it is a scam. Please report the incident to the local police or cybercrime unit. Your trust and safety are important to us. Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations. The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world. Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, ...

As an API Regulatory Affairs Manager, your role involves ensuring that API regulatory activities are carried out according to the specified time schedule and ensuring timely readiness of API regulatory documents/DMFs for new submissions/updates. You will be required to provide necessary regulatory support, advice, and guidance to the concerned API manufacturing sites and R&T Unit. Additionally, you will need to assure the quality of DMF submissions and maintenance, taking into consideration the company's Intermediates business. Your responsibilities also include providing technical inputs to Section Heads for APIs and Key for regulatory adequacy. Key Responsibilities: - Co-ordinate and colla...

QA In-Charge (Late Phase) The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Responsibilities 1. Review and maintain QMS documents like SOPs, Change control, deviations, events. 2. Responsible for conducting Internal/External audits (i.e., Investigator site audits) for Clinical Trial Projects to ensure compliance with SOPs, Protocol, ICH GCP, quality system and applicable regulatory requirements. 3. Responsible for planning, conducting, and reporting of system audit of clinical trial, clinical data ma...

Inspect incoming, in-process, and final products as per quality standards. Prepare and maintain QMS documents, inspection reports, and test certificates. Please call- 9845514305 / 8050011328 for further details.

As an Assistant Production Packing Manager/Manager, your role will involve overseeing the day-to-day production planning and execution to meet the requirements. You will be responsible for supervising and evaluating the performance of production personnel, organizing workflow to meet specifications and deadlines, and ensuring staff/worker distribution according to production planning. Your key responsibilities will include reviewing, approving, and implementing departmental SOPs based on current guidelines, monitoring online documentation such as BMRs/BPRs/Log books, and overseeing the stage-wise process for product yield. Additionally, you will be responsible for monitoring and reviewing QM...

As an Assistant Manager/Manager in Production Packing, your role will involve the following responsibilities: - Responsible for day-to-day production planning and execution as per requirement. - Supervise and evaluate the performance of production personnel. - Organize workflow to meet specifications and deadlines. - Manage staff/ worker distribution, allocation, and arrangement as per production planning. - Review, approve, and implement departmental SOPs as per current guidelines. - Monitor and maintain the status of online documentation such as BMRs, BPRs, Log books, and other necessary documents. - Monitor the stage-wise process for product yield. - Review and monitor QMS documents, qual...

Position :- Sr. Officer / Executive Department :- QA - Qualification & Validation Job Location :- Ranu, Vadodara Experience:- 3-8 years, Regulated MARKET industry. Role & responsibilities Preparation of Validation Master Plan. Responsibility for initiation, review and co-ordination for QMS documents such as Change Control, Deviation, CAPA etc. Preparation and review of SOP related to startup of new facility. Preparation and review of Qualification documents i.e. URS, FS, DQ, FAT, SAT, IQ, OQ & PQ. Coordination with other cross functional team for the execution of validation projects. On-site execution of validation protocols, report generation and participating in on-site qualification or co...

As a Senior Manager - Production (OSD) at Sun Pharmaceutical Industries Ltd, your responsibilities will include: - Planning production and packing activities to meet monthly targets - Reviewing daily production activities for various processes like Granulation, Compression, Coating, Capsule filling, Inspection, Packing, and Nutra section - Ensuring Good Documentation Practices (GDP) are followed at the shop floor and packing area - Coordinating with various departments like IPQA, QC, Engineering, PPC, SCM, EHS, and FDD/MSTG for smooth functioning of production and packing activities - Handling SAP related work in production and ensuring online documentation as per cGMP practice - Implementin...

Role Overview: You will be responsible for product development activities of all injectable dosage forms for regulated markets including General injectable, Onco, and Peptide products. You will need to have a good understanding of ANDA and 505b2 product filing, as well as exposure to a wide range of dosage forms such as liquid solution, lyophilized, and suspension. Your role will also involve understanding Drug device combination products and regulatory expectations. You will be experienced in preparing and reviewing product development reports, MFR, stability protocols, study protocols, SOPs, and have a basic understanding of implementing QbD principles for formulation development. Key Resp...

Title Executive - R&D Quality Business Unit R&D Quality Job Grade G12A Location: Vadodara Key Responsibilities At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Position Summary List of Responsibilities: To Review and approve o...

You will be responsible for the following tasks as Officer - API at Dishman Carbogen Amcis Limited in Bavla, Gujarat, IN: - Handling Manufacturing Compliance activities such as IPQA Activity - Managing QMS Documents including CAPA, OOS, and Change control - Handling APQR processes - Managing Batch release activities - Demonstrating strong communication skills - Having exposure to Regulatory audits If you possess the necessary qualifications and experience for this role, you are encouraged to apply.,

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, E...

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 e...

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 develo...

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...

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, corp...

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 ra...

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.,