Provides strategic planning and implementation for the Quality System, including CGMP, GLP regulations, US 21 CFR Part 11 and guidelines to determine the impact to Quality Assurance Systems. Responsible for CAPA,OOT,OOS,Change Control & Deviations.
Oversee the implementation, maintenance, and continuous improvement of GLP systems and processes. Investigate and resolve any GLP-related deviations, non-conformances, or audit findings. Develop and maintain SOPs related to GLP compliance.
Regular Batch Analysis by using LCMS & GCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS Experience in E&L by GCMS
GTI & NDSRI by using LCMS. Review of Method Development & Method Validation Data Preparation of Protocols & Validation Reports Handling of Incidents, Deviations & Change Controls.
Handling of Laboratory Incidents, Change Control, Deviations OOS & OOT Handling of CAPA, Coordinate with technical team for timely closure of QMS documents. Writing SOP's. Support Internal & External Audit Finding Responses.
Responsible for Erection of Transformer, commissioning & testing Responsible for testing and Operation of DG sets. Troubleshooting and Preventive Maintenance & Testing of all types Pharma of Electrical and Mechanical Equipment’s.
HPLC Analysis Method Validations Method Developments. Calibrations. Forced Degradation Studies Required Candidate profile HPLC Analysis
Well versed with peptide characterization and analysis. Strong knowledge of amino acid sequencing, peptide finger printing and HMW impurity screening. Knowledge and hands on experience in handling of LC-MS/MS, LC-HRMS/QTOF, HPLC-SEC Required Candidate profile Knowledge of peptide characterization with and without enzyme digestion techniques. Experience in handling of large molecules, ADC’s, oligonucleotides is an added advantage
Regular Batch Analysis by using LCMS. Preparation and analysis of method validation, method transfer, method verification and method development protocols and reports. Experience in GTI & NDSRI by LCMS
Ensure Lab Safety Management Activities Organizing Safety Committee Meeting Responsible for Safety Training to Employees Conduct Periodic Mock Drill & Fire Drills as per Schedule Responsible for PCB activities
Responsible to Maintain and Monitoring the Daily, Weekly, Monthly Data Backup Schedules in Standalone, Servers. Managing the Vendor Qualification related to IT. Preparation & Review of IQ, OQ, PQ protocols and reports based on the requirement.
Handling of Vendor Qualification activities Handling of Document Controlling:issuing, retrieval & Archiving Involvement in Regulatory Audits Trainings to QC team on revisions of SOPs, Specifications and test procedures Documentation management system
Perform IVRT studies for topical and transdermal products Conduct in IVPT using human /animal skin in Franz diffusion cells. Develop methods for topical dosage forms for content/assay and RS estimation.
Analytical Data Review. Review of Electronic audit trails for the techniques of LCMS, GCMS, ICPMS. Review of Analytical Method Validations, Method transfers, protocols, reports. Experience in review of LCMS, GCMS, ICPMS. calibration data.
- Lead BD for pharma/analytical testing - Drive domestic & global client acquisition - Handle key accounts & contract negotiation - Develop growth strategies & manage team - Exp. in lab services - Drive global client growth
Oversee the implementation, maintenance, and continuous improvement of GLP systems and processes. Investigate and resolve any GLP-related deviations, non-conformances, or audit findings. Develop and maintain SOPs related to GLP compliance.
Job Title: Analyst / Senior Analyst IVRT / IVPT Company: Energon Labs Location: Hyderabad Employment Type: Full Time, Permanent Role Overview We are looking for skilled Analysts / Senior Analysts with expertise in IVRT (In Vitro Release Testing) and IVPT (In Vitro Permeation Testing) . The role involves performing studies on topical and transdermal products, conducting diffusion experiments, and developing analytical methods to support pharmaceutical R&D. Key Responsibilities Conduct IVRT studies for topical and transdermal formulations. Perform IVPT studies using human/animal skin with Franz diffusion cells. Develop and validate methods for topical dosage forms, including content/assay and related substances (RS) estimation. Maintain accurate records and ensure compliance with regulatory and GLP/GMP standards. Collaborate with cross-functional teams to support R&D and product development. Troubleshoot analytical methods and optimize processes as required. Desired Candidate Profile Education: Postgraduate (M.Sc. in Chemistry/Pharmaceutical Sciences or related discipline). Experience: 3 - 8 years in IVRT/IVPT studies within pharmaceutical or CRO environments. Strong understanding of topical/transdermal formulations and diffusion methodologies. Familiarity with regulatory guidelines (FDA, EMA, ICH) and compliance standards. Excellent problem-solving, documentation, and communication skills. Role & Department Role: Analyst / Senior Analyst (IVRT/IVPT) Department: R&D / Analytical Services Industry: Pharmaceutical & Life Sciences Category: Research & Development / Analytical Testing
Job Title: Vice President Business Development (Pharma/Analytical Lab) Company: Energon Labs Location: Hyderabad (Kukatpally) Employment Type: Full Time, Permanent Role Overview We are seeking a seasoned Vice President Business Development to lead our business growth strategy. The role involves spearheading client acquisition (domestic & international), managing key accounts, driving strategic partnerships, and expanding global presence in analytical testing and lab services. Key Responsibilities Lead business development initiatives for pharmaceutical and analytical testing services. Drive domestic and global client acquisition through strategic outreach and partnerships. Manage key accounts and oversee contract negotiations. Develop and execute growth strategies to meet business objectives. Build, mentor, and manage the business development team. Identify new market opportunities and expand service reach globally. Collaborate with technical and operations teams to align client requirements with service delivery. Represent the organization at industry events, forums, and client meetings. Desired Candidate Profile Education: Postgraduate in any discipline (MBA preferred). Experience: 16 - 22 years in Business Development / Sales leadership roles within pharmaceutical/analytical lab services. Proven expertise in enterprise and B2B sales with global exposure. Strong negotiation, relationship management, and strategic planning skills. Experience in managing high-value accounts and building long-term client relationships. Demonstrated ability to lead teams and achieve revenue targets. Role & Department Role: Sales Head (B2B) Department: Sales & Business Development Industry: Pharmaceutical & Life Sciences Category: Enterprise & B2B Sales
Job Title: AQA Quality Assurance (LCMS, GCMS, ICPMS) Company: Energon Labs Location: Hyderabad Experience Required: 2 - 6 years Employment Type: Full Time, Permanent Role Overview We are seeking experienced professionals in Analytical Quality Assurance (AQA) to review and ensure compliance in analytical data generated through LCMS, GCMS, and ICPMS techniques. The role requires a keen eye for detail, strong knowledge of analytical methods, and the ability to uphold the highest quality standards. Key Responsibilities Review analytical data for LCMS, GCMS, and ICPMS techniques. Conduct electronic audit trail reviews for analytical instruments and ensure compliance. Review Analytical Method Validations (AMVs), Method Transfers, protocols, and reports. Verify and review calibration data of LCMS, GCMS, and ICPMS instruments. Ensure compliance with internal quality systems and regulatory guidelines. Provide feedback and corrective action recommendations to analytical teams. Desired Candidate Profile Education: Postgraduate in Chemistry - M.Sc. (Analytical/Organic/General Chemistry) or equivalent. Experience: 2 - 6 years in Quality Assurance, specifically with LCMS/GCMS/ICPMS data review. Strong knowledge of analytical instrument compliance and validation requirements . Attention to detail, accuracy, and documentation skills. Familiarity with pharmaceutical/life sciences quality systems. Role & Department Role: Quality Assurance Other Department: Quality Assurance Industry: Pharmaceutical & Life Sciences Category: Quality Assurance – Other
Perform Feasibility Studies Analysis by using IC. Prepare and execute method validation protocols. Document & Report method development data. Design & optimize IC methods of detection of inorganic anions, cations, counterions residuals&impurities. Required Candidate profile Ion Chromatography
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