Career

Number of position - 01

Year of Experience - 07 - 10 Yrs

Qualification - M.Pharma/ B.Pharma/ M.Sc.

Job Description 

• Ensure Regulatory Compliance: Ensure manufacturing processes, quality systems, and final products meet the standards set by regulatory bodies.
• License Verification: Ensure the facility holds required licenses and manufactures products as per the loan license agreement.
• Establish and maintain a QMS aligned with GMP to ensure product quality from raw materials to final release.
• Prepare and maintain SOP system related to Third Party Manufacturing, Contract Manufacturing and Loan License Manufacturing.
• To conduct manufacturing site Audit.
• Works closely with the licensee to ensure manufacturing processes meet the loan license agreement, licensor requirements, and regulatory standards.
• To evaluate and qualify suppliers of raw materials, packaging materials, and other components. 
• Regularly monitor Key Quality Indicators like batch rejection rates, deviations, complaints, and audit findings to ensure continuous improvement.
• To ensure batch records are completed accurately and in compliance with regulatory standards. This includes reviewing the batch production records, equipment logs, and in-process checks.
• Oversee the validation of manufacturing processes (e.g. equipment validation, process validation) to ensure that they produce consistent and high-quality products.
• Responsible for investigating deviations & CAPA and risk management. 

Number of position - 01

Year of Experience -04 - 06 Yrs

Qualification -M.Pharma/ B.Pharma/ M.Sc.

Job Description 

• Prepare and submit product test license, Import license for RLD and API.
• Prepare and review standard operating procedures (SOPs) of equipment, instruments & facilities. 
• Plan and execute reverse engineering of RLD and marketed products.
• Conduct Pre-formulation and formulation studies to evaluate the physical and chemical properties of drug substances and drug products.
• Develop and optimize formulation for various dosage forms, including tablets, capsules, Pellets, liquids, and injectables.
• Perform stability studies and ensure formulation meets stability requirements.
• Prepare and review technical documents, including formulation development, and stability study protocol reports.
• Ensure compliance with regulatory documents and company quality standards.
• Coordinate with Analytical, Regulatory, Stores, Purchase, Project management, and Development quality assurance teams to support product development and regulatory submissions.
• Troubleshoot formulation-related issues and provide solutions to improve product performance.
• Maintain laboratory equipment and ensure proper calibration and maintenance.
• Participate in technology transfer activities to manufacturing sites.
• Other roles and responsibilities assigned by the Manager and R&D Head.

Number of position - 01

Year of Experience - 06 - 07 Yrs

Qualification - M.Sc. (Chemistry)/ M.Pharma

Job Description 

• Can prepare SOP/STP/Protocol as per SOP and guideline 
• Can perform GLP activity i.e., Daily verification, calibration of instruments, qualification with documentation. 
• Can perform analysis on HPLC, GC, LCMS, Dissolution and other analytical instruments with trouble shooting. 
• QMS related knowledge about, Change Control, Lab incident, Out of Specification, Out of Calibration, Deviation, CAPA and others. 
• Can perform analytical method development, validation and QC analysis as per GLP. 
• Audit preparation and compliance 

Number of position - 01

Year of Experience - 00 - 01 Yrs

Qualification - M.Sc. (Chemistry)/ M.Pharma/ B.Pharma

Job Description 

• Can prepare SOP/STP/Protocol as per SOP and guideline 
• Can perform GLP activity i.e., Daily verification, calibration of instruments,qualification with documentation. 
• Have basic knowledge and can perform analysis on physicochemical laboratory i.e.; titration, Karl Fischer and auto titrator, IR Spectroscopy, UV spectrophotometer, Polarimeter, Dissolution, Coulometer and analytical preparation. 
• QMS related knowledge about, Change Control, Lab incident, Out of Specification, Out of Calibration, Deviation, CAPA and others. 
• Can perform analytical method development, validation and QC analysis as per GLP. 
• Audit preparation and compliance 
• Any other tasks assigned by reporting manager / Head of Department

Number of position - 01

Year of Experience - 05 - 07 Yrs

Qualification - M.Sc. (Chemistry)/ M.Pharma

Job Description 

• Can prepare SOP/STP/Protocol as per SOP and guideline 
• Can perform GLP activity i.e., Daily verification, calibration of instruments, qualification with documentation. 
• Can perform analysis on HPLC, GC, LCMS, Dissolution and other analytical instruments with trouble shooting. 
• QMS related knowledge about, Change Control, Lab incident, Out of Specification, Out of Calibration, Deviation, CAPA and others. 
• Can perform analytical method development, validation and QC analysis as per GLP. 
• Audit preparation and compliance 

Number of position - 01

Year of Experience - 05 - 07 Yrs

Qualification - M.Sc. (Chemistry)/ M.Pharma

Job Description 

• Can prepare SOP/STP/Protocol as per SOP and guideline 
• Can perform GLP activity i.e., Daily verification, calibration of instruments, qualification with documentation. 
• Can perform analysis on HPLC, GC, LCMS, Dissolution and other analytical instruments with trouble shooting. 
• QMS related knowledge about, Change Control, Lab incident, Out of Specification, Out of Calibration, Deviation, CAPA and others. 
• Can perform analytical method development, validation and QC analysis as per GLP. 
• Audit preparation and compliance 

Reports To: Chief Operating Officer / Business Operations Director
Type: Full-Time

About the Role:

We are seeking a dynamic and highly organized Business Operations Executive Assistant to provide top-tier administrative and operational support to our executive team. This role is essential in ensuring the seamless management of day-to-day operations, strategic initiatives, and executive priorities. The ideal candidate is proactive, detail-oriented, and excels at multitasking in a fast-paced environment.

Key Responsibilities:

1. Executive Support:
• Manage calendars, coordinate meetings, and handle travel arrangements for Director.
• Prepare and organize materials for meetings, presentations, and events.
• Serve as a point of contact for internal and external stakeholders on behalf of Director.
• Draft, proofread, edit and send reports, emails, and other documentation pertaining to Sourcing of the products and Sales on behalf of the Director.
2. Operational Coordination:
• Support business operations by assisting with data analysis, reporting, and tracking key performance metrics of Business Development, Sales and Operations Departments.
• Assist with project management tasks, including planning, scheduling, and follow-up on action items.
• Collaborate with cross-functional teams to ensure timely execution of strategic initiatives.

1. Communication & Stakeholder Management:
• Communicate effectively with internal teams, clients, and vendors to support operational activities.
• Assist in managing communications between Director and stakeholders to foster positive relationships.
• Support HR functions, including onboarding new team members, organizing team events, and managing employee engagement initiatives.
2. Documentation & Records Management:
• Maintain comprehensive and organized records for all executive and operational documents.
• Ensure documentation is updated, archived, and easily accessible for quick reference.
• Track project milestones and deliverables, reporting progress to the executive team regularly.
3. Process Improvement:
• Identify and implement improvements to optimize administrative processes and workflows.
• Assist in developing standard operating procedures to streamline operational tasks and enhance productivity.

Requirements:

• Education: Bachelor’s degree in Business Administration, Operations Management, or a related field preferred.
• Experience: Minimum of 3-5 years of experience as an Executive Assistant or similar role in business operations, preferably in a fast-paced or startup environment.
• Skills:
• Excellent organizational, time management, and multitasking skills.
• Strong written and verbal communication abilities.
• High proficiency in MS Office Suite, Google Workspace, and project management tools (e.g., Asana, Trello).
• Familiarity with data analysis tools and CRM software is a plus.
• Other Attributes:
• High level of discretion, professionalism, and confidentiality.
• Ability to work independently, anticipate needs, and exercise sound judgment.
• A proactive attitude, with an eagerness to contribute to company goals.

Benefits:

• Competitive salary and benefits package.
• Opportunities for professional growth and career advancement.
• Engaging and collaborative work culture.
• Flexible work environment with potential for hybrid work.

This role offers the opportunity to work closely with senior leadership, gaining insights into high-level strategic decision-making while contributing to the overall success of our organization. If you are a driven, organized, and motivated individual, we’d love to hear from you!

Year of Experience- 8-10

Qualification- Bachelor’s degree in Business Administration/ Pharma/ Science

• Develop and execute sourcing strategies to meet the company`s procurement goals and objectives.
• Identify, evaluate, and select suppliers based on quality, cost, and delivery performance.
• Negotiate contracts and agreements with suppliers to secure favorable terms and conditions.
• Monitor and manage supplier performance, addressing any issues related to quality, delivery, or cost.
• Collaborate with internal stakeholders, including R&D, production, and finance, Sales to understand sourcing needs and requirements.
• Collaborate with oversees regional teams based at LATAM, APAC & India.
• Conduct market research and analysis to stay informed about industry trends, market conditions, and emerging suppliers.
• Implement and maintain best practices in sourcing and procurement processes.
• Develop and manage the sourcing budget, ensuring cost-effective procurement practices.
• Prepare and present reports on sourcing activities, supplier performance, and cost savings to senior management.
• Foster strong relationships with suppliers and internal teams to ensure smooth and efficient procurement operations.
• Identify the potential suppliers from China for regulated market especially Brazil, LATAM etc.
• To maintain the product data base of the respective suppliers from China & APAC
• Excellent in communication, negotiation and presentation skills
• Strong problem-solving skills and a proactive approach to driving business improvements.

Company Overview- Headquartered in India - Ahmedabad, Molkem`s global footprint spans over three distribution centers across India, Dubai, and Brazil, complemented by subsidiaries in Brazil, Vietnam and Dubai & sales offices in Argentina and Colombia.

Our upcoming state-of-the-art R&D and analytical development center in Ahmedabad, India, is set to offer R&D, Tech Transfer and CDMO services for oral solids, parenteral and novel drug delivery systems.

Determining financial objectives.

• Designing and implementing systems, policies, and procedures to facilitate internal financial control. 
• To formulate KRAs/KPIs for yourself and your team at the beginning of the financial year and its monthly monitoring.  
• Preparing Annual Budget and forecasting trends. 
• Develop reports for top management summarizing the business`s financial position in areas of income, expenses, capital usage, and cash flows, and coordinate the preparation of strategic plans, budgets, and financial forecasts. 
• Developing and updating accounting, finance, and management policies and procedures. 
• Effective Cash Flow Management. 
• Monitoring budgets and comparing them with actual costs and revenues related to purchase, marketing, and capital. 
• Coordinating the preparation, maintenance, and filling of projected P&L Accounts, Bills Discounting, and Balance Sheets as required by bank authorities and other financial institutions. 
• Coordinate the preparation of Financial Statements, Financial Reports for internal usage. 
• Getting control accounts reconciled and sorting out the discrepancies. 
• Liaison with business-related organizations such as Banks, RBI, ECGC, etc.., and preparing budgets, i.e., systemizing departmental work. 
• Handling Reserve Bank of India queries for export/import matters and carrying out all correspondence with the bank. 
• Filing GST returns, E-TDS payments & E-TDS quarterly returns, independent handling of GST, TDS & Income tax assessment. 
• Furnish ROC and Company secretary compliance and Statutory Audit. 
• Carry out and finish GST assessment and audits. 
• Remitting foreign currency for import advance & other expenses like traveling, consultancy, advertising, and project export. 
• Profitability and capex monitoring of Domestic as well as all foreign subsidiaries. 
• Digitized various MIS reports that can be extracted from ERP systems and linked to POWER BI tools. Reports reflect real-time data which helps management decision-making at the contract review level.  
• Finalization of books of accounts of overseas subsidiaries. 
• Closely reviewing accounting of related party and inter-department transactions.  
• Negotiating with the banks for export documentation requirements. 
• Opening LC for inland and foreign parties, bank guarantee for the import & PCB for the purchase, ECGC Policy. 
• Processing of Purchase Bills of Raw Material, Assets & Passing Bills of expenses from various departments.

Overview:

We are seeking a highly motivated Regulatory Affairs Specialist to join our dynamic research Centre. The ideal candidate will have a strong background in regulatory requirements and compliance within the scientific research industry. This role plays a crucial part in ensuring that our research activities meet all applicable regulatory standards and guidelines.

Responsibilities:

• Develop and implement regulatory strategies to support research projects and product development initiatives.
• Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. 
• Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements.
• Collaborate with cross-functional teams to integrate regulatory considerations into project timelines and deliverables.
• Conduct regulatory reviews of research protocols, study reports, and other scientific documents to ensure compliance with regulatory requirements.
• Communicate with regulatory agencies as necessary to facilitate approvals, responses to inquiries, and other regulatory interactions.
• Maintain current knowledge of regulatory landscape changes and provide updates and training to internal stakeholders as needed.
• Participate in internal and external audits and inspections related to regulatory compliance.

Qualifications and skills:

• Bachelor’s degree in a science, pharmacy, or a related field; advanced degree (e.g., Master’s, PhD) preferred.
• Minimum of 8- 12 years of experience in regulatory affairs within a research environment, preferably in a Pharmaceutical, Biotechnology industry.
• Demonstrated understanding of regulatory requirements and guidelines relevant to scientific research, including experience with reference listed product confirmation
• Strong organizational skills and attention to detail with the ability to manage multiple priorities in a fast-paced environment.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
• Ability to independently solve problems and make decisions, exercising good judgment in ambiguous situations.
• Proficiency in MS Office (Word, Excel, PowerPoint) and experience with regulatory software and databases.