Research Associate – II Nitrosamines

Manager – ADL GMP

Supervisor II Assembly

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Quality Senior Lead

Industrial Sales Engineer

F&B sales Engineer

Accountant

Job Overview: <ul><li>The Research Associate – II – Nitrosamines is responsible for conducting analytical research, method development, and risk assessment activities focused on nitrosamine impurities in pharmaceutical products.&nbsp;</li><li>The role supports regulatory compliance, safety assessment, and mitigation strategies in line with global regulatory requirements (such as those from the FDA, EMA, WHO, and ICH M7). This position requires a strong understanding of organic chemistry, analytical instrumentation, and impurity profiling.</li></ul> Responsibilities: <ul><li>Development, validation, and transfer of LC/MS methods for quantitative determination of Nitrosamine impurities (Small Molecules and NDSRIs) at ppm to sub-ppb levels</li><li>Design and execution of experiments to identify root causes of Nitrosamine formation and develop mitigation strategies</li><li>Perform chemical extractions of container closure systems and drug product solutions</li><li>Utilize advanced mass spectrometry techniques (LC-MS and GC-MS) for identification and quantification of Nitrosamines</li><li>Prepare technical reports and support documentation for regulatory filings</li><li>Collaborate with subject matter experts, supervisors, and cross-functional teams</li><li>Interpret analytical data, evaluate results, and incorporate findings into project goals</li><li>Maintain compliance with relevant Quality System Regulations and GxP standards</li></ul> Requirements: <ul><li>Experience: 6–10 years in analytical chemistry focused on Nitrosamines</li><li>Education: Master’s degree or equivalent experience; PhD preferred with relevant experience</li><li>Skills Required:</li><li>Proficiency in LCMS/GCMS instrumentation and troubleshooting</li><li>Strong knowledge of Nitrosamine chemistry and analytical techniques</li><li>Experience in method development, validation, and regulatory reporting</li><li>Ability to analyze complex data and draw meaningful conclusions</li><li>Good documentation and technical report writing skills</li></ul>

Role Description: <ul><li>The Manager –ADL, GM P is responsible for leading analytical development activities within a GMP-regulated environment, ensuring robust method development, validation, and transfer for pharmaceutical products.</li><li>This role plays a critical part in supporting product development, regulatory submissions, and commercial manufacturing by providing accurate and compliant analytical data.</li></ul> Responsibilities <ul><li>Lead and manage a team involved in method validation, method transfer, and postproduction studies (Freeze Thaw analysis, Photostability studies, Dilution studies, RLD Characterization, etc.) for 505b(2) and generic ANDAs.</li><li>Troubleshoot and resolve challenges during method validation and method transfer of new products from R&amp;D to manufacturing sites.</li><li>Support regulatory filings and respond to analytical function queries.</li><li>Ensure compliance with cGLP within the ADL GMP function.</li><li>Provide support during quality inspections by regulatory agencies at manufacturing plants.</li><li>Timely closure of LIR, NCR, CCN, CAPA and ensure implementation of corrective and preventive actions.</li><li>Ensure timely compliance with Pharmacopoeia updates.</li><li>Mentor, coach, and develop team members for task execution and personal growth.</li><li>Collaborate with external partners (CRO/CMO) for analytical testing execution.</li><li>Work cross-functionally with project management, regulatory affairs, formulation development, manufacturing, and quality control teams.</li></ul> Requirements: <ul><li>Education: Ph.D. OR MPharm.</li><li>Experience: 3–4 years of team handling experience.</li></ul> Skills Required: <ul><li>Strong knowledge of analytical method validation, method transfer, Pharmacopoeia compliance, cGLP, and documentation practices.</li><li>Sound understanding of analytical techniques with good learning agility.</li><li>Excellent technical writing and computer skills for data recording, protocol/report generation, and presentations.</li><li>Strong coordination, relationship management, and ability to work in multicultural teams.</li><li>Effective communication and team management skills.</li><li>Knowledge of latest quality and regulatory requirements.</li><li>Ability to delegate effectively and take autonomous decisions.</li><li>Critical thinking skills for problem-solving and decision making.</li></ul>

Responsibilities: <ul><li>To Plan and establish production work schedule to meet delivery times and best utilize company production capacity by releasing work orders.</li><li>Scheduling for materials and production in Coordination with staff throughout the company to ensure timely delivery to customers by obtaining agreement for product ship dates.</li><li>To take full responsibility of the shift in terms of management of staff, management of production and quality targets and to ensure the smooth running of the production processes, produced within the shift in line with the company’s quality systems, processes and procedures.</li><li>To demonstrate excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered during the shift in line with the companies Health and Safety policy.</li><li>Confer with other supervisors and managers to coordinate operations and activities within or between departments.</li><li>Monitor, measure, and report on production related process performance/KPI’s, general issues and ensure the team is self-managed (SMT) on problem solving and troubling shooting skills to identify root causes and take fast effective action to resolve the problems in hand.</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Demonstrate customer centric approach and adherence to customer expectations to promote a positive company image.</li><li>Responsible for on-the-job training of directs. Play active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li><li>Set departmental process and link to ISO procedure.</li><li>Stake holder Management</li></ul> Requirements:&nbsp; Professional Experience <ul><li>5 to 7 Years of experience in the same field and industry.</li><li>Bachelor’s degree in mechanical or Electronics Engineering</li><li>Advanced skills with Microsoft Office, especially Excel</li></ul>&nbsp;Leadership Experience: <ul><li>Deep understanding and professional experience of people management.</li><li>Excellent communication and convincing skills</li><li>Self-driven and detail-oriented</li><li>Desire to solve problems with analytical thinking</li><li>Good at people management and execution skills</li><li>Strong organizational skills and a team player</li></ul>&nbsp;Project Experience: <ul><li>Expert in material and production planning.</li><li>Knowledge of SAP</li><li>Quality and Environmental Management System knowledge</li><li>Excellent people management skills to develop and motivate direct reporting staff and to ensure that Health and Safety rules and regulations are adhered to during the shift in line with the companys Health and Safety policy</li><li>Assist in maintaining stock rooms and inventory accuracy and participate in physical inventory counts.</li><li>Play an active role in the TEOA plan/Kaizen initiative to achieve plans for future growth within the company.</li></ul>&nbsp;Qualifications: <ul><li>Bachelor of Science or above degree and an engineering background.</li><li>Preferably Mechanical, Electrical/Electronics, and Industrial Engineer</li></ul>&nbsp;Other Requirements: <ul><li>3-5+ years’ experience as a practitioner as an Engineer.</li><li>Knowledge in Mechanical, Electrical, and Pneumatic drawings.</li><li>Solid understanding of health and safety regulations and practices.</li><li>Strong decision-making and problem-solving skills.</li><li>Excellent communication and interpersonal skills.</li><li>Computer literate with capability in email, MS Office, and related communication tools.</li><li>Knowledge in various machines from Stamping, Molding, Plating, and Assembly.</li></ul>

Role Description: <ul><li>The MPDE Automation Manager will lead a team of automation engineers tasked with developing assembly processes for high-speed cable assemblies and coordinating with the Thailand manufacturing engineering team on the transition to mass production.</li></ul> Responsibilities: Lead a team of engineers who will: <ul><li>Develop cable assembly automation lines in accordance with LEANPD product development.</li><li>Drive for excellence in existing automation technologies and methods.</li><li>Strive to implement new automation technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for automation manufacturability.</li><li>Realizes proof of concept tooling, product samples and prototypes.</li><li>Act as the binding element between product development and automation engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with project management team to understand current and future strategic business needs.</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need.</li></ul> Requirements: <ul><li>Bachelor or above degree with mechanical/electric related majors.</li><li>At least 5 years related experience managerial level in multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in cable assembly automation is preferred.</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC reference standard reconciliation and disposal.</li><li>Tracks inventory of reference standards in the lab.</li><li>Uses laboratory software for reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with reference standards.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Coordinates, with lab management, in-house qualification of reference standards. Submit samples to the appropriate lab groups for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure reference standards and laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the status of reference standard inventory.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting reference standard processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative. maintenance, reference standard/sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.	continuous.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of reference standard/sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computers.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills.</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements	 <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision.</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Role Description: <ul><li>Work with Parts leadership team to develop Quality system for Parts operations and implement.</li><li>Drive quality improvements in Receiving, storage, Packaging and shipping.</li><li>The position will be responsible for both Product quality and process quality.</li><li>The position will also oversee quality awareness program to educate and empower teams to drive quality function in their departments.</li></ul> Responsibilities: <ul><li>Develop and implement robust quality assurance processes for incoming, in-process, and outgoing tractor spare parts.</li><li>Conduct inspections and audits to ensure adherence to company and industry standards using Demerit system.</li><li>Collaborate with suppliers to maintain the quality of purchased parts.</li><li>Manage dealer return and claim management including issuance of credit notes to customers.</li><li>Drive quality awareness program to improve skill levels of warehouse teams with respect to Quality.</li><li>Mistake proof processes to ensure zero defects flowing to customer.</li></ul> Requiresments: <ul><li>Quality management experience of 2 – 3 years is preferred</li><li>Experience / exposure to best practices for packaging of spare parts in warehousing environment.</li><li>Exposure and experience in use of quality tools like APQP, FMEA, and SPC will be plus.</li><li>Understanding of Lean six Sigma Principles</li><li>Must be Proficient in Microsoft Excel, Outlook and SAP</li><li>Excellent data analysis skills and analytical mindset</li><li>Ability to work in a team environment</li><li>Excellent communication skills.</li><li>Ability to read, write, and speak the English language is required.</li><li>Bilingual (Spanish) is a plus</li><li>While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.</li><li>The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl.</li></ul>

Responsibilities: <ul><li>Conduct market research to identify potential customers in the Industrial Sector in North India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the Process Industries in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements:﻿ <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industrial, with a specific focus on pumps used in Process Industry applications.</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Region coverage South India (Andhra Pradesh / Telangana /Karnataka / Tamil Nadu / Kerala).&nbsp;</li><li>Conduct market research to identify potential customers in the F&amp;B&amp;S Sector in South India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from the concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the PI - F&amp;B&amp;S in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements: <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industry.&nbsp;</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Conduct market research to identify potential customers in the Industrial Sector in North India.</li><li>Develop and implement targeted marketing strategies to reach potential customers in these sectors.</li><li>Key account management including End Users, OEMs &amp; System Integrators</li><li>Build long-term customer business relations right from concept phase and ensure product standardization at customer sites.</li><li>Build and maintain relationships with existing customers in these sectors, identifying opportunities for cross-selling and upselling.</li><li>Attend industry events and exhibitions to showcase company products and engage with potential customers.</li><li>Provide technical expertise and assistance to customers, helping them to select the most suitable equipment for their specific applications in these sectors.</li><li>Act as the customers advocate and ensure their technical needs are met.&nbsp;</li><li>Work closely with the company product development team to identify and develop new products that meet the specific needs of the Process Industries in India.</li><li>Produce and maintain detailed documentation on all customer interactions, including project timelines, equipment specifications, and budget constraints.</li><li>Provide ongoing technical support and guidance to other departments within the company as required to ensure that all customers receive the highest level of service and support.</li><li>Provide high-quality technical support to prospects and customers during pre- and post-sales situations.&nbsp;</li><li>Understand and solve challenging application problems by recommending appropriate company solutions.&nbsp;</li><li>Update records in CRM interface for opportunity pipeline, appointments, lead and present business analytical data through CRM&nbsp;</li></ul> Requirements: <ul><li>Hold relevant Diploma Mechanical / Bachelor of Engineering, Qualifications and a strong business background.</li><li>Preferably have at least 10 -15 years of experience in the Fluid Handling Industrial, with a specific focus on pumps used in Process Industry applications.</li><li>Possess excellent written and spoken English communication skills.</li></ul>

Responsibilities: <ul><li>Issue and mail tax invoices to customers, entry tax invoice information in the customers’ system if needed.</li><li>Enter entries in the accounting system.</li><li>Response for organizing and checking the employee reimbursement and payment documents.</li><li>Reconciling the related control accounts.&nbsp;</li><li>Support finishing monthly and yearly closing.</li><li>Support annual/internal audit.</li><li>Assist in organizing financial documents.</li><li>Handle other work or project assigned by manager.</li><li>Maintain and update internal records and reports.</li><li>Provide administrative support to ensure smooth daily operations.</li></ul> Requirement:﻿ <ul><li>Experience: 3+ yrs</li><li>Strong written and spoken English</li><li>Detail-oriented, self-motivated, and able to meet deadlines under pressure</li></ul>

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118 asc control system dcs Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Supervisor II Assembly

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Quality Senior Lead

Industrial Sales Engineer

F&B sales Engineer

Industrial Sales Engineer

Accountant

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118 asc control system dcs Jobs found

Research Associate – II Nitrosamines

Manager – ADL GMP

Supervisor II Assembly

Automation Department Manager (Automation MPDE Department Manager)

Reference Standard Coordinator

Quality Senior Lead

Industrial Sales Engineer

F&B sales Engineer

Industrial Sales Engineer

Accountant

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.