Role & responsibilities Maintenance & Troubleshooting of process equipment compression (Fette, Sejong), Coating & CVC Line. Maintain records of preventive and breakdown maintenance. Handle computerized system SCADA and update the basic programs of PLC. SKILLS Experience in process equipment in OSD pharma plant. Knowledge of 21CFR part 11 & cGMP. Should have knowledge of calibration. Should be able to work in a dynamic environment.

Role & responsibilities Responsible for review of In process, Raw materials, Intermediates, Recovered materials, Finished products, Tech transfer samples and Cleaning verification / validation samples using current Specification, STP,GTP and associated wet chemistry and instrumental techniques as appropriate. Prepare and review specifications, sampling instructions, test methods, analytical work records and other QC procedures. Responsible for review of instrumental analysis as per the Matrix of analyst / microbiologist validation. Preparation and review of training matrix & training plan. Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports. Prepare and review study protocol and report for Quality control activities Preparation & review various quality documents such as SOPs, validation protocols and reports. Responsible for review of calibration of QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, pH meter, Conductivity meter, UV spectrophotometer and refractometer etc Responsible for preparation, review, tracking of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule. Ensure the tracking and follow up for the Method Validation, Verification & Analytical Method Transfer Activity. Planning and Execution of Method Validation, Verification & Analytical Method Coordinate with service engineer during preventive maintenance and breakdown of QC instruments. Responsible for verification of Laboratory chemicals, Reagents and Indicators. Review of logbooks in Quality Control Department and Responsible for monthly audit trial review for instrument. Preferred candidate profile Must have experience in Quality Control department in reputed pharma organizations. Should have hands on experience of Instrument Handling Strong knowledge of operating HPLC, GC, KF, IR, pH Meter etc. One Should Manage day to day Planning Should review method validation, Verification & Analytical Method Transfer Activity. One should timely review of calibration / verification of instruments. Ensure timely review preventive maintenance of instruments. Should review of records of QC testing. One should Timely review of logbook entries & daily monitoring activities.

Role & responsibilities Responsible for technology transfer activities from lab scale to commercial scale. Maintain individual training records. Prepare and approve P&ID and PFDs. Prepare PFDs, mass balance and perform HAZOP study. Prepare trial reports. Draft, review, and approve TMPR and MPR documents. Design and review of critical equipments & approve GA drawing. Calculate Utility and effluent load. Co-ordinate for design, installation, and qualification activities. Maintain environment, health & safety parameters within company premises. Prepare controlling budgets for OPEX (material, consumables etc.) and contribute to CAPEX planning. Prepare, review, and approve the documents relevant to process development lab. Execution of SAP related activities. Act as a Functional Administrator (FA) for managing training activities for respective department in LMS. Perform daily operations in process development lab. Preferred candidate profile Proven experience in Technology Absorption & Validation department within a reputed API pharma organization. Hands-on expertise in the execution of validation activities for process control system. In-depth knowledge in execution of validation and scale up batches for all the products to be manufactured at site. Sound knowledge of SAP and BOM Creation. Proficiency in drafting and reviewing of SOP’s, HAZOP, TTR, etc. Excellent Communication and problem-solving skills. Should be assertive, proactive, and self-driven. Ability to work in adynamic environment.

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU, UK and AUS-NZ. Review of documents related to compilation of dossiers and query responses. Up to date knowledge of regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD /eCTD requirements for modules 2 and 3 is mandatory. Hands on experience with compilation of module 1 and portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.

RESPONSIBILITIES Coordination with the customer to compile the dossier as per current registration regulations in SEA & East Africa markets. Coordination with the customer at various registration stages to obtain approval. Analyze the molecule and determination for need of Bioequivalence or bio waiver studies. Life cycle management of product license by filing renewals and analyzing the type of variation needed to be based on the proposed changes to DMF, formulation, packaging, or excipients. Review and approve the artworks as per Brazil and Canada market regulations. Interpretate deficiencies received compile and submission responses within the stipulated time frame. Maintenance of tracker for submission and deadline for responses and coordination with stakeholders to submit responses within stipulated deadlines. DESIRED SKILLS Good knowledge of Registration requirements in ROW market. Experience in submission of generic medicine dossiers to the ROW market. Good technical knowledge, review skills and understanding of regulatory submissions Strong knowledge of CTD/ ACTD requirements for submission of dossiers to SEA , ME & AFRICA markets. Good analytical and problem-solving skills. Ability to try new approaches when faced with challenges. Should have a good analytical and learning attitude. Proactive to submission of response to any queries. Good communication skills.

RESPONSIBILITIES Assist in annual budget & analysis and monitor against actuals. Asist on S&OP (sales & operations planning) process. Align production schedules for three formulation plants based in India. Ensure smooth supplies. Monthly resource verification execution done based on plan for formulation plants. Analysis of production planning based on open orders. Be part of At Risk meeting with US team to ensure reduction in numbers of product in At Risk. Work out a plan based on priority to reduce air shipments. Monitor production and despatches on daily basis with respect the plan. Doing PO reconciliation with customers. Getting MOD from US and sharing with the plant and ensuring despatches. Monitor and achieve sales and customer demand for monthly/quarterly/yearly basis. Monitor project management for timely tech transfer, launch, and commercialization of the products in various markets. Generation and circulation of fortnightly sales reports Tracking of manufacturing against line plan. Giving Captive API requirements to API team for planning. Also tracking of API despatches to Captive as per shared schedule. Continuous monitoring of Demand vs Forecast vs Actuals. Supervise material procurement based on demand received from various markets. Oversee the day-to-day operations in terms of materials planning, purchasing, manufacturing, release, dispatch & delivery. Develop and use a supply chain dashboard through Power BI Provide daily, weekly monthly MIS reports as and when required. DESIRED SKILLS Hands-on experience in handling planning and budgeting activities in formulation plant. Experience in manufacturing line plan for Solid oral & injectable. Knowledge of formulation manufacturing. Must have strong experience in SAP operation, Advance Excel Proactive approach to internal and external queries. Excellent coordination skills. Ability to pivot and try new approaches when faced with challenges. Should hold high standards of business ethics Optimize to handle complexity. Very Good communication skills.

RESPONSIBILITIES Book-in, Data Entry and Quality Reviewer of ICSR in Argus database ICSR Global Submission (Timelines and Submission Process) Vendor Management SOP training in department as and when needed DESIRED SKILLS Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines. Good knowledge about timelines and submission process of Global ICSRs w.r.t to multiple health authorities. Good knowledge about Global submission mailbox, maintenance of submission data and trackers of all ICSR submission activities including correspondence with regulatory authorities and submission records for audits and inspection readiness. Basic knowledge of Computers Good Communication skills

Responsibilities Review quality documents prepared by Packaging department which includes material specification, instructions and MPCR II before issuing to plant. Ensure and review change control, deviations, CAPA, logs & database. Prepare training calendar, provide periodic training & monitor any revisions to packaging SOP and applicable CQA Guidelines. Implementation of DMS systems. Ensure compliance with respect to yearly departmental audit by CQA and submit compliance report. Validation of software and equipment for packaging development. Conduct monthly meetings with all Unichem sites for packaging deliverables & coordinate with plant teams for the approval and release of documentation as per plant requirement. Handle computer validation systems for packaging development related software. Audit the packaging material vendor for cGMP compliance. Create timeline tracker along with a workplan of packaging deliverables. Create Master Data sheet for all documentation. Assign monthly document changeovers to team members & ensuring the reconciliation of the same. Implement Quality Improvement Measures. Reduce non-compliance in Packaging Departments with an objective of enhancing the quality with respect to all points (Documents, System, Procedure, Planning). DESIRED SKILLS Experience in the Packaging department of a reputed pharmaceutical organization. Thorough knowledge of softwares and equipements required in packaging. Experience in quality, documentation, planning and regulatory procedures and compliances required for packaging department. Should have excellent planning and coordination skills. Must have a keen eye for details. Should be willing to work in a dynamic environment. Should be a team player

RESPONSIBILITIES Compilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage. Publishing in eCTD format and submission to respective Regulatory Agencies. Compilation and submission of variation applications for EU and/or UK. Review of documents related to compilation of dossiers, variations and query responses. Up to date knowledge of EU regulatory guidelines and requirements. DESIRED SKILLS Must have hands on experience on using eCTD software and e-publishing requirements throughout project lifecycle Should have handled initial MAA submission & Variations for EU. Good technical knowledge with respect to solid oral dosage forms. Adept at review of manufacturing and analytical documentation from a regulatory perspective. Strong knowledge of CTD /eCTD requirements and hands-on experience with compilation of CTD modules 1 to 5 is mandatory. Hands on experience with portal submissions would be preferable. Ability to try new approaches when faced with challenges. Should have good analytical and learning attitude. Good communication (written and oral) and inter-personal skills.