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5.0 - 9.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Parts Operation Quality Manager at Siemens Energy, you will leverage your proven experience in handling quality control functions for Spare Parts Operations at the manufacturing facility in Naroda. Your responsibilities will include managing both manufactured and outsourced components, demonstrating knowledge of compression products, suppliers, and customers, and ensuring adherence to quality aspects and manufacturing processes. You will independently optimize the quality control function related to spare parts operations, oversee supplier quality and parts inspection, align customer quality requirements with SE standards, and work collaboratively to achieve and enhance key performance ...
Posted 3 months ago
4.0 - 9.0 years
1 - 4 Lacs
Vasai
Work from Office
1. Preparation of Annual/Periodic Product Quality Review (APQR/PQR) 2. Preparation of finished product specification (Tablet, External preparations & Injection) 3. Preparation of Protocol and Reports of PROCESS VALIDATION Batches. Required Candidate profile 4. Handling of Incidents, Deviation, CCP, OOS, OOT and Material Rejections 5. Issuing BARCODES for new Registered products in coordination with regulatory 6. MARKET COMPLAINTS and CAPA.
Posted 3 months ago
15.0 - 18.0 years
15 - 17 Lacs
Navsari
Work from Office
Role & responsibilities Responsible for defining QA strategy, approach and execution in the field of document control, IPQA, qualification/validation, GLP, training activities etc. and responsible for leading and directing QA team To approve SMF, VMP, quality manual and validation protocol. To conduct internal audit / self-inspection to ensure compliance to GMP and another regulatory requirement. To arrange management review meeting and escalate the outcome of quarterly report to management. To handle the Market Complaints and to participate in Product Recall. To approve quality system documents likes Change controls proposals, Deviations, Incident reports, CAPA reports, OOS and OOT, NCR, Ma...
Posted 3 months ago
8.0 - 12.0 years
0 Lacs
haryana
On-site
The Procurement Engineer is responsible for conducting procurement activities with both local and foreign vendors in adherence to the company's procedures, code of ethics, local content regulations, and QHSE policy. This includes managing procurement processes for mechanical equipment and package items such as Raw gas Compressors, Dehydration units, Gas Sweetening systems, Chiller units, Air Coolers, Pumps, Heat Exchangers, Vessels, Tanks, OH cranes, Chemical Injection Skids, and more. You will be required to request commercial offers, align material requests with supplier proposals, coordinate with the technical department to resolve any discrepancies, evaluate commercial offers, negotiate ...
Posted 3 months ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
SBM Offshore is seeking a detail-oriented individual to join our Project Management team in Bangalore, IN. As part of our team, you will play a crucial role in supporting the Category Manager in managing strategically important suppliers and sourcing key external workers globally. Your responsibilities will include analyzing spend related to the category, leading vendor qualification activities, negotiating and contractualizing agreements with suppliers, and developing long-term relationships with strategic suppliers. Key Responsibilities: - **Strategy:** Assist the Category Manager in managing suppliers and sourcing external workers efficiently. Collect and analyze spend related to the cate...
Posted 3 months ago
3.0 - 6.0 years
9 - 15 Lacs
Pune
Work from Office
We have an opening for one of our prestigious product based company Experience: 3 to 6 Years Budget: upto 15 LPA (As per exp range) Location: Pune, Maharastra Notice: Immediate to 15 days Work Mode: Work from office Must Have: Should be proper documents Skills: Siemens opcenter, Quality management, Defect Tracking, Inspection, Vendor Qualification, QM Process, SAP Interfaces Job Description IT Consultant CAQ Systems (Opcenter Quality) Together we make the difference Siemens Mobility is an independent managed company of Siemens AG. Its core business includes rail vehicles, rail automation and electrification solutions, turnkey systems, intelligent road traffic technology and related services....
Posted 3 months ago
5.0 - 8.0 years
7 - 11 Lacs
Navi Mumbai
Work from Office
Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience
Posted 3 months ago
12.0 - 15.0 years
11 - 16 Lacs
Navi Mumbai
Work from Office
Work Experience 12 to 15 years of experience in Pharma Vendor Audit Management 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3. To execute vendor Audits, CAPA tracking, and qualification documentation 4. To schedule and monitor the Vendor Audits 5. To work on VQ special projects in coordination with Project IT team 6. To track the project till its implementation and Go Live across all sites Technical , behavioral & managerial 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 5. Result Orientation 3. Customer Centricity Education Masters in Pharmacy Post ...
Posted 3 months ago
3.0 - 7.0 years
2 - 4 Lacs
Neemrana
Work from Office
Role & responsibilities 1. Primarily Responsible for Vendor Qualification and Vendor Approval accordingly and compilation of documents. 2. Handling of Issuance and Retrieval of batch number, batch manufacturing record, batch packing record, Register, Logbooks, SOPs, Formats, worksheets protocols, Analytical protocols of all departments. 3. Preparation, Review and compilation of the Annual Product Quality Review. 4. To prepare and review of quality and other departments SOPs. 5. Responsible for preparation and up-dation of quality assurance SOPs. 6. Responsible for preparation and up-dation of SOP’s Index of all the departments. 7. To handle and maintain specimen signature, job description et...
Posted 3 months ago
8.0 - 10.0 years
7 - 8 Lacs
Ranipet
Work from Office
Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...
Posted 4 months ago
8.0 - 10.0 years
7 - 8 Lacs
Ranipet
Work from Office
Co-ordination for all the site (KOPL) with respect to dispatch activity from outsourcing site. Approving all procedures impacting the quality of intermediates or APIs e.g. SOPs, specification, standard test procedures, protocols etc. Coordination for Handling market complaints / Returns/Deviations / OOS. Handling change controls, deviations, market complaints, returned goods, product recall, OOS/ OOT, self inspection and corrective & preventive actions with respect to outsourcing site. Releasing or rejecting all APIs/ intermediates as per QMS systems for all the products which are manufactured at outsourcing site Organization of regulatory and customer Audits Organization of Meeting / Semina...
Posted 4 months ago
10.0 - 18.0 years
12 - 22 Lacs
Navi Mumbai, India
Work from Office
Job Responsibilities: 1. Monitoring and Assessment of QMS related activities for all API sites (Nerul, Chiplun and Ambernath) and Govandi (CPRL, PAN, BRL etc.). 2. Change Controls: Review and closure of change controls, approval and closure of actions childs, CQA Assessment etc., 3. Review of Customer Complaints, Risk Assessments, Deviations, CAPAs, Investigations, Recalls etc., 4. Handling of Customer Quality agreement and co-ordination with cross functional team till execution of the agreement. 5. Tracking of CQA SOPs as per the review date, by maintaining the SOP Periodic review tracker and master SOP list. 6. Preparation/Revision of CQA SOPs and making master, effective after completion ...
Posted 4 months ago
3.0 - 6.0 years
36 - 60 Lacs
Navi Mumbai
Work from Office
Responsibilities: * Lead QMS implementation & compliance * Ensure product quality through data review & annual product quality reviews * Conduct BMRRs, batch releases & equipment qualifications Office cab/shuttle Provident fund
Posted 4 months ago
6.0 - 10.0 years
4 - 8 Lacs
Dahej
Work from Office
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.Ap...
Posted 4 months ago
0.0 - 6.0 years
1 - 4 Lacs
Dadra & Nagar Haveli
Work from Office
Responsibilities: * Conduct BPR reviews, BMR reviews, process validation & cleaning validations. * Ensure compliance with industry standards during equipment & water validations. Accidental insurance Annual bonus Leave encashment Gratuity Provident fund
Posted 4 months ago
4.0 - 8.0 years
4 - 7 Lacs
Pune
Work from Office
Roles and Responsibilities Conduct equipment qualification, validation, and vendor qualification activities according to established procedures. Perform process validation protocols, reports preparation, and CAPA implementation as required. Ensure compliance with regulatory requirements by maintaining accurate records of documentation and data analysis. Collaborate with cross-functional teams to identify areas for improvement in validation processes. Develop and execute test plans for new equipment installations or modifications.
Posted 4 months ago
7.0 - 12.0 years
5 - 10 Lacs
Hyderabad/ Secunderabad
Work from Office
Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audi...
Posted 4 months ago
2.0 - 5.0 years
2 - 4 Lacs
Vadodara
Work from Office
Roles and Responsibilities Ensure compliance with cGMP guidelines during documentation review, approvals, and vendor qualification. Conduct artwork checking, document preparation, FDCA applications, OOS investigations, and factory coordination. Review documents such as BMR/BPR/SOPs/protocols for quality control purposes. Coordinate with cross-functional teams to ensure smooth operations. Desired Candidate Profile 2-5 years of experience in a similar role within the pharmaceutical industry. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Science (MS/M.Sc). Strong understanding of Good Manufacturing Practices (cGMP), Document Management Systems (DMS), Quality Control procedures.
Posted 4 months ago
5.0 - 10.0 years
5 - 9 Lacs
Ahmedabad
Work from Office
> Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. > Desired Candidate Profile: Bachelor's or master's degree in engineering, life sciences, or a related field. A minimum of 6 years...
Posted 4 months ago
5.0 - 10.0 years
7 - 7 Lacs
Navi Mumbai, Mumbai (All Areas)
Work from Office
1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION
Posted 4 months ago
6.0 - 10.0 years
6 - 15 Lacs
Hyderabad
Work from Office
Role & responsibilities JD- Designation: Deputy manager Department: QA Role: vendor qualification Experience:6-10 years of relevant experience. 1)Preparation and Review of procedures related to Vendor management as per regulatory requirements. 2. Review of QMS elements like Change management (Change control), Deviation, CAPA, related to external testing laboratories, service providers. 4. Management of vendor qualification (Related to Contract services/ contract Labs /CMO) documentation i.e. initiation of vendor assessment, tracking of their audit and periodic monitoring. 5. Responsible for vendor Audit Schedule, Execution of site audit for Contract Testing Laboratories, Contract Service Pro...
Posted 4 months ago
8.0 - 13.0 years
4 - 9 Lacs
Mumbai, Mumbai Suburban, Mumbai (All Areas)
Work from Office
Role & responsibilities Lead the vendor qualification process, including the evaluation and approval of new and existing vendors. Review and approve vendor documentation to ensure compliance with internal standards and regulatory requirements. Manage QMS notifications, ensuring timely resolution of issues related to change control, deviations, and CAPA. Oversee the preparation, review, and approval of SOPs to ensure alignment with current practices and regulatory standards. Conduct comprehensive risk assessments and risk analysis to identify potential quality issues and implement mitigation strategies. Independently plan, conduct, and report on vendor audits, coordinating with internal and e...
Posted 4 months ago
10.0 - 15.0 years
14 - 16 Lacs
Pune
Work from Office
Quality Management System: Oversight/Handling of Handling of Change Control, Incident / Deviation and CAPA. Following and tracking of Change Control, Incident /Deviation and CAPA. Involved in the investigation activity whenever required. Ensure that products are manufactured in compliance to Regulatory requirements and as per Good Manufacturing Practices. Ensure that production and manufacturing activities are undertaken in compliance to SOPs, systems, procedure and GMP/GLP requirements. Maintain GMP compliance in various departments to manage the production in line with the current GMP requirement. Handling of Change Control, Deviation, risk assessment and CAPA as per company procedure Veri...
Posted 4 months ago
2.0 - 5.0 years
3 - 5 Lacs
Ahmedabad
Work from Office
Management of the Technical document needed for the specific grade of the product Knowledge of material qualification and certification part 2-5 years of experience in pharmaceutical, API or excipient regulated industries
Posted 4 months ago
2.0 - 7.0 years
3 - 7 Lacs
Gangtok, Rangpo
Work from Office
HIRING! We are Hiring for Quality Assurance Department with OSD Background: QUALITY ASSURANCE Open Positions: Officer/Sr. Officer - 2 to 7 years Desire Profile : 1. Hands on experience of review of batch record and COA. 2. Well-versed in schedule M and others regulatory guidelines. 3. Knowledge of export documentations. 4. Exposure of handling regulatory and customer Audits. Interested candidates may share updated resume at hr.plant@zuventus.com
Posted 5 months ago
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