Quality Assurance Manager FDA APPROVED
Eastern Petroleum Private Ltd.
- 5 Years - 10 Years
- As per industry standard
- Mumbai
Job Description
Check all SOPs of QC available
Check the record of cleanliness of the area.
Check the list of instrument/equipment update
Check that activities like sampling, testing and handling of special chemicals are done by taking proper precautions.
Check that labeling are done on samples withdrawn and after passing.
Check standardization of reagent/solution and labeling.
Check whether signed specification and method of analysis are available.
Check the calibration record of instrument/equipment.
Check the calibration chart for all instrument/equipment.
Check all the analyst qualified and record available.
Check the stability sample against stability schedule.
Check the stability record against stability program.
Check whether water sampling is done as per sampling plan.
Check the analysis record of water for chemical and microbial tests.
Check the record of standardization of volumetric solution.
Check the sample entry register and ensure sampling is done as per sampling plan.
Check any analysis record to ensure that analysis is done as per specification and test procedures are strictly followed.
Check approved vendor list available and updated.
Check number of out of specification since last audit.
Check and issue of BMR/BPR.
Check the medical examination report.
Check the record for cleaning of water tank.
Check entry and exit of personnel’s and visitors record.
Check and keep pest control record.
Taking approval for new product and made necessary document.
Keep track on training record (in house /external).
Vendor audits
Keep the record of hazardous material.
Prepare new BMR for new product.
Keep the inventory for glassware and chemicals.
Keep the record for finished goods.
Check the storage condition for raw materials and finished goods.
Keep the record of stereo control.
Check the status labeling.
Keep the log book for instrument.
Area monitoring and pressure differentials.
Monitoring of quality of water.
Maintain the record of preventive maintenance.
Keep the record of calibration and validation method.
Keep the record of stability studies, Change control, Deviation, MFR’s.
Maintenance of working standards.
Records of control sample.
As on when Management Assigned any Job.
Dispensing/checking of dispensed RM/PM.
Process validation.
Regulatory affairs.
Preparation of SOPs
QC related routine activities(periodic checking of QC reports and records)
MFR writing and BMR management.
Documentation control.
Complaint handling.
Face FDA inspection, ISO audit, outside party inspection.
Face Internal audit.
Worked as chemist in QC lab handling all day-to-day work. Familiar with IP BP & USP
Methods of analysis. Analysis of raw material & finished products having experience in good laboratory practices. Made GLP By control Charts & In
House QC samples & Standards
Participated in round robin analysis with different laboratories like shell & sabic
Familiar With ASTM, UOP & IP methods of testing
Actively Participated in Interview Recruitment of new Chemist
Having excellent safety and attendance record.
Authorized For IATA to sent samples & Dangerous Goods by air
Made Laboratory Hygiene plan & Quality Check Plan
• Good hands on experience of handling a team and lead the same to complete the task
• Responsible for budgeting, procurement of laboratory equipment and supplies for smooth functioning of department
• Overall controlling activities of quality function & fulfilling credential related to IMS, customer complaints and other requirements.
• Excellent analytical chemistry knowledge related to the Speciality chemicals and related products and testing with different instrumentations
• Responsible for the product quality, technology transfer and new product development for growth of Joint Venture
• Excellent knowledge for formulation of Drilling fluid products as per customer’s requirement
• Responsible to follow the test method as per API & ASTM guidelines for petroleum products
• Excellent knowledge for hyphenated techniques like GC-MS, ICP-MS and other instruments like GC, AAS, CHNS analyzer , FTIR, UV-VIS spectrophotometer and many for quantification for crude oil and other petroleum products
• Sound in new method development, method validation as per standard guidelines
• Expertise in QMS, OHSAS, EMS & NABL lab accreditation
• Good knowledge of product formulation as per customer demand
• Sound knowledge of ISO 17025 and it’s implementation for good analytical skills
• Conversant with new vendor selection criteria and timely audit for product quality improvement
• Good negotiation skills
• Handling regional QA and Sustaining Lab for Fluid section
• Provide analytical and technical support to internal and external customer as and when required as per policy
• Maintains laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair
• Maintains laboratory productivity by monitoring workload of functional areas; identifying peak and slack periods; making operational or staffing adjustment
• Implements new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress
• Maintains quality results by participating in the various round robin programs; performing proficiency surveys; reviewing quality control and quality assurance programs; adjusting in policy and procedures; generating reports; maintaining records
• Maintains laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; writing user manuals; training employees; maintaining security and confidentiality
• Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies
• Maintains laboratory staff by recruiting, selecting, orienting, and training employees
• Prepares chemists by teaching analytical theory, testing methodology, and the importance of following correct test practices
• Leader of Sustaining team (Eastern Hemisphere Region) to develop cost effective alternative products as per market requirement
• Work with global supply chain team for product related tenders and give technical support to the local vendor for qualification
• Lead to develop new indigenous products as per market requirement for global supply
• Technical support to the operation team related to the product as per requirement from client
• Developed Invert Emulsifiers, Organo-clay, Lubricants, Wetting Agents, Viscosifer and Fluid loss control agents for different mud systems as a part of Sustaining group
• Leader of QA/QC regional lab for incoming products and related testing as per Schlumberger QA guidelines for Quality Control
• Work with Global QA team for amendments of product’s test, test specification as per needs
• Work coordinately with supply chain team for product quality control and supplier’s performance to enhance the quality
• Responsible to develop diverse types of drilling fluid systems with whole documentations as per client’s scope of work
• Solely responsible for quality check of drilling fluid products from the local vendors
• Responsible for laboratory Quality, Health, Safety and Environment related documentation
• Vendor visits and audits as a part of vendor evaluation as per Product Approval Guidelines
• Member of Schlumberger Product Sustaining, QA, Analytical Support and Technical Service Global Team
• Responsible for documentation control for regional QA and Sustaining lab
• Handling team of people responsible for QA and Sustaining group activities with proper training
• Facilitator for Joint Venture (Hindustan MI Swaco, Panoli and Dahej, Gujarat) along with additional work in Technical Service Laboratory
• Effectively interact with Production and Development teams to maintain product supply and help introduce new products.
• Working with purchasing staff to establish quality requirements from external suppliers to formulate cost effective product.
• Ensuring compliance with national and international standards and legislation.
• Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.
• Supervising technical staff in carrying out tests and checks.
• Responsible for the new product formulation and its development as per tender requirements from the customer.
• Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC
• Formulation of Liquid and Solid products used in Drilling fluid industries or as per Customer’s demands namely; Lubricants, Oxygen Scavengers, Biocides, Lignite products, Cellulose based products.
• Assessing the product specifications of the company and its suppliers, and comparing with customer requirements
• Technology transfer from MI Swaco, Houston to Hindustan MI Swaco for business growth.
• Controlling the process, plant and laboratory operations along with the ISO documentations for the continuous growth.
• Responsible for Quality and process improvement for achieving company’s growth.
• Set up documentations and process as per Quality Management System (QMS).
• Laboratory internal audits, Plant audit and Process audit for smooth functioning.
• Responsible for cost effective formulation that meets customer’s demand.
• Vendor visit and new vendor development for Quality and cost of product.
• Responsible for supplier audit as a part of QMS activity
• Source of raw materials with consistency and their audit as per New Vendor Evaluation
• Interaction with customers for better and consistent quality of the materials.
• To control the documentation for OHSAS and EMS for the entire plant as per Policy.
• Responsible for set up of new Formulation and Application lab in the premises.
• Responsible for analytical support as and when needed for Quality improvement.
To ensure the line clearance during manufacturing and packing operations.
• Online filling of BMR & BPR.
• Sampling of intermediate, Bulk and Finished product for QC analysis.
• Sampling and protocol fill up of Validation batches.
• Implementation of cGMP, and Good Documentation Practices.
• Handling of IPQC equipment.
• Continuous vigilance to ensure conformance to SOPs, Packing instruction and prevention or
Risk throughout the plant to avoid mixups and cross Contamination.
• Collection, Storage and maintaining the records of control sample.
• Physical Observation of Control Sample.
• Destruction of Control sample.
• Records and Updation of Control Sample Register.
• Withdrawal of Control Sample as needed.
• Maintaining records of Control Sample Physical
Monthly Auditor for lab
Education : - Master degree in Analytical chemistry
Job Information
- Job Type: Full Time
- Industry: Petrochemicals
- Function : Production/Maintenance/Manufacturing/Packaging
- Specilizations: Production/ Manufacturing/ Maintenance
- Role: Quality Assurance - Manager, Quality Assurance/ Control
- Qulification: Any Graduate, B.Sc, M.Sc
- Key Skills: QAQCQMSQuality CheckNABLFinished ProductsISO 17025IPQCQuality AssuranceQuality Control
About Company
- Eastern Petroleum Private Ltd.
-
MANUFACTURING OF PETROLEUM PRODUCTS LUBRICANTS ,GREASES, AND SPECIALITY OILS
Similar Jobs
PRODUCTION Monitoring, PAPER MFG, PUNE
- 1 Years - 12 Years
- Pune
Quality Manager
- 6 Years - 8 Years
- Shimla
Assistant Manager QC
- 1 Years - 12 Years
- Kolkata
Stores Assistant
- 1 Years - 6 Years
- Kasaragod, Tiruvalla
Electrical Engineer for Cable Industry ( New Plant )
- 6 Years - 19 Years
- Mohali
Technical Service Specialist
- 8 Years - 13 Years
- Mumbai
Assistant Manager / Deputy Manager - Visual Inspection- Packing
- 6 Years - 11 Years
- Bengaluru/ Bangalore
Asceptic Manufacturing - Fill Finish
- 3 Years - 8 Years
- Bengaluru/ Bangalore