Avantika Medex

Planning of work Responsible for overall analysis work in lab by handing team Documentation Reports preparation Review AMV OOS, OOT SOP Preparation.

Company Overview: We are a reputed pharmaceutical company specializing in the manufacturing of Oral Solid Dosage (OSD) formulations. Committed to high-quality standards and regulatory compliance, we are looking for a dynamic and experienced professional to join our Quality Control team. Job Purpose: The Assistant Manager Quality Control will oversee and manage day-to-day QC operations to ensure compliance with cGMP, GLP, and regulatory requirements for OSD manufacturing. This role is critical for maintaining product quality and supporting internal and external audits. Key Responsibilities: Supervise and lead a team of QC analysts and chemists in routine testing of raw materials, in-process samples, finished products, and stability samples. Review and approve analytical data, reports, and documentation in compliance with regulatory standards (USFDA, MHRA, EU, etc.). Ensure adherence to SOPs and perform periodic reviews and updates of QC procedures. Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory incidents, and implement CAPA. Coordinate and support analytical method validation, method transfer, and instrumentation qualification. Maintain and calibrate laboratory instruments such as HPLC, GC, UV, IR, and Dissolution testers. Assist in audit readiness and participate in regulatory and customer audits. Maintain LIMS or other data management systems effectively. Prepare and deliver periodic training sessions for QC staff. Desired Candidate Profile: Education: M.Sc. (Chemistry), B.Pharm, or M.Pharm Experience: 6–10 years in Quality Control within a regulated OSD manufacturing environment Skills: Hands-on experience with HPLC, GC, and other analytical instruments Sound understanding of cGMP, GLP, ICH guidelines Good documentation and review skills Proficiency in handling OOS/OOT and deviations Strong communication, leadership, and team management abilities Why Join Us? Opportunity to work in a growing, globally compliant pharma facility Competitive salary and performance-based incentives Strong focus on career development and technical training

Role & responsibilities 1. Responsible for analysis of FG and Raw materials 2. Ensure adherence to GMP & cGMP 3. Maintain and calibrate GC instrument 4. Prepare and review analytical documents and reports Preferred candidate profile B.Sc./M.Sc/ or B.Pharm. Hands on experience in GC operation Familiarity with regulatory audits

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Country Experience Required: Uzbekistan, Kazakhstan, Azerbaijan, Turkmenistan and Tajikistan Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study. Experience Required: CDSCO , USFDA, EUGMP, NAFDAC Dosage Form Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

Company Name : Avantika Medex Pvt Ltd Job Title : Sr. Officer / Sr. Executive Formulation & Development (F&D) Department: Formulation & Development Formulation Location: Plant (Chachravadi Vasana) Reporting To: Manager / Senior Manager – F&D Experience Required: 3 to 8 Years Qualification: B.Pharm / M.Pharm (Pharmaceutics or relevant specialization) Job Summary: We are looking for a technically sound and motivated Formulation and Development Executive with 3 to 8 years of experience in the pharmaceutical industry. The candidate will be responsible for the development of solid oral dosage forms (tablets, capsules, etc.), execution of pre-formulation studies, lab-scale trials, and coordination for scale-up and technology transfer. Key Responsibilities: Develop formulations for oral solid dosage forms (OSDs) such as tablets, capsules, and powders. Conduct pre-formulation and excipient compatibility studies . Prepare and execute laboratory trials and pilot batches . Optimize formulations based on stability and performance results. Coordinate with Analytical, QA, RA, and Production departments for seamless project execution. Prepare product development reports (PDRs), batch manufacturing/packing records (BMR/BPR) , and technology transfer documentation. Ensure adherence to GMP, ICH, and regulatory guidelines throughout development stages. Support scale-up, exhibit batches, and validation in the manufacturing plant. Assist in investigation and troubleshooting during development and commercial stages. Keep abreast of latest developments in formulation technologies and regulatory trends. Key Skills & Competencies: Strong technical knowledge of formulation science, excipients, and process equipment. Hands-on experience in granulation, compression, coating , and packaging of OSDS. Working knowledge of QBD, DOE, AND PROCESS OPTIMIZATION . Understanding of regulatory requirements (USFDA, MHRA, EU, WHO).

Job Title: Microbiologist Experience: 01 - 03 Years Salary: 2 3.5 LPA Location: Gallops Industrial Park 2, Vasna Chacharvadi, Ahmedabad Job Summary: We are seeking a skilled and detail-oriented Microbiologist with 1 to 3 years of experience to join our quality and laboratory team. The ideal candidate will be responsible for conducting microbiological testing, ensuring compliance with industry standards, and maintaining proper documentation as per regulatory norms. Key Responsibilities: Conduct microbiological analysis of raw materials, in-process samples, and finished products. Perform environmental monitoring and hygiene audits within the production facility. Identify and isolate microorganisms using various culture techniques and instruments. Maintain and calibrate microbiology lab equipment as per SOPs. Prepare and maintain accurate test reports and lab records. Ensure compliance with GMP, GLP, and safety protocols. Coordinate with Quality Assurance/Quality Control and production teams on microbiological issues. Participate in internal audits and assist in regulatory inspections. Ensure proper storage, handling, and disposal of microbial cultures and biohazard materials. Desired Candidate Profile: Bachelor’s or Master’s degree in Microbiology or related life sciences. 1 to 3 years of relevant industrial experience in a microbiology laboratory (pharma/food/cosmetics preferred). Work Location: Gallops Industrial Park 2, Vasna Chacharvadi, Ahmedabad

Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master Formula Records (MFR), Manufacturing Process Records (MPR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR) . Review and analyze the Annual Product Quality Review (APQR) to assess product performance and compliance. Prepare and review Standard Operating Procedures (SOPs) to ensure alignment with regulatory guidelines and internal standards. Review Stability Study Protocols and Reports to support product shelf-life determination. Oversee the preparation, review, and execution of Qualification and Validation activities for equipment, systems, and processes. Review and monitor the Training Plan to ensure effective implementation and documentation of employee training. Review and maintain Document Control Procedures to uphold quality and compliance standards. Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.

Job Title: Accounting Officer / Executive Location: Ahmedabad Department: Finance & Accounts Reporting To: Head of Finance Employment Type: Full-Time Key Responsibilities: Maintain and update general ledger accounts and prepare journal entries. Handle accounts payable and receivable processes, including vendor payments and customer invoicing. Perform monthly, quarterly, and annual financial closings. Prepare financial statements, MIS reports, and reconciliations (bank, vendor, customer, inventory). Ensure compliance with applicable tax regulations (GST, TDS, Income Tax, etc.) and support tax filings. Support internal and external audits by providing required documentation and explanations. Assist in budgeting, forecasting, and variance analysis. Manage inventory accounting and coordinate with the warehouse team to ensure proper stock valuation and controls. Monitor cost accounting related to raw materials, production batches, and finished goods. Ensure accurate documentation and accounting of R&D expenses, samples, and promotional materials. Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.

Department: Production Location: Plant ( Bavla) Shift: Rotational Shifts (Day/Night/General) To ensure smooth execution of capsule filling operations within the Oral Solid Dosage (OSD) manufacturing section, ensuring compliance with cGMP standards, safety protocols, and production targets. Key Responsibilities: Operate, monitor, and manage capsule filling machines (e.g., Bosch, ACG Pam, Fette, etc.) within the OSD manufacturing unit. Supervise and guide operators and contract workforce during production shifts. Ensure accuracy and completeness of Batch Manufacturing Records (BMRs) and adherence to Standard Operating Procedures (SOPs) . Perform line clearance , conduct in-process quality checks , and ensure all documentation meets regulatory compliance. Troubleshoot minor equipment issues and escalate to the engineering team when needed. Maintain cleanroom hygiene , production line cleanliness, and 5S practices . Ensure compliance with cGMP, GDP, EHS , and other quality systems in daily operations. Participate in regulatory audits (USFDA, MHRA, WHO, etc.) and ensure readiness at all times. Maintain inventory and reconciliation of raw materials, packing materials, and tools specific to the capsule filling line. Support continuous improvement initiatives , reduce wastage, and optimize machine utilization. Availability for extended hours or weekends if production demands. Willingness to work in rotational shifts (Morning / Evening / Night). Experience in regulated pharmaceutical environments (USFDA, WHO, MHRA-approved plants) Sound knowledge of OSD processes, capsule filling machinery, GMP documentation, and SOPs

Department: Production Location: Plant ( Bavla) Shift: Rotational Shifts (Day/Night/General) To oversee and ensure smooth operation of sachet filling machines within the pharmaceutical production line, maintaining compliance with cGMP standards, safety protocols, and production targets. Key Responsibilities: Operate, monitor, and manage sachet filling machines (e.g., automatic sachet packing machines, multi-lane sachet fillers). Supervise and guide machine operators and contract manpower during shift operations. Ensure adherence to Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs) . Perform line clearance , conduct in-process quality checks , and maintain accurate production documentation. Troubleshoot minor equipment issues and coordinate with maintenance for timely resolution. Maintain good housekeeping , cleanroom standards, and compliance with cGMP , HSE , and quality requirements. Support continuous improvement activities to enhance line efficiency and reduce downtime. Participate in regulatory audits (USFDA, WHO, MHRA, etc.) and maintain audit readiness. Maintain inventory of raw materials and packing materials for sachet filling operations. Ensure timely shift handovers and maintain proper communication across teams. Experience in regulated markets (USFDA/WHO/MHRA approved plants) Relevant experience in sachet filling or pharmaceutical packaging in a regulated pharma environment. Knowledge of sachet filling machinery, pharmaceutical packaging processes, GMP documentation, and SOP compliance

Role & responsibilities Design and develop packaging artwork including labels, cartons, leaflets, blisters, and shrink sleeves for pharmaceutical products. Ensure artwork complies with local and international regulatory guidelines (e.g. FDA, EMA, CDSCO). Coordinate with cross-functional teams including Regulatory Affairs and Marketing, Production and QA/QC) Prepare print-ready files as per printer specifications (CMYK/PMS, dielines, resolution). Maintain version control and proper documentation of all artwork revisions. Proofread and verify all text elements (drug name, strength, composition, batch info, etc.) for accuracy. Use design software such as CorelDRAW, Adobe Illustrator, Photoshop or other industry tools. Basic understanding of pharmaceutical packaging and regulations. Understanding of printing processes (offset, flexo, digital). Knowledge of barcode generation, Braille text standards, and serialization requirements. Knowledge of GMP (Good Manufacturing Practices) and packaging processes. Good communication and coordination abilities. Artwork Preparation Experience Required: Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories. Preferred candidate profile Experience with artwork management software: CorelDRAW, Adobe Illustrator, Photoshop Understanding of printing processes (offset, flexo, digital). Knowledge of barcode generation, Braille text standards, and serialization requirements