Role & responsibilities To maintain facility and equipment. - To procure engineering consumables, proprietary spares and to maintain inventory of the same. - To perform and to approve Qualification studies for equipment (Plant and Utility) and Facility. - To schedule and to execute preventive maintenance program for plant equipment and utility equipment. - To review and to participate in process validation program. - To maintain and to update drawing like plant layout, equipment layout, P & ID for equipment (Plant and Utility), HVAC system etc. - To schedule and to execute Annual Maintenance Program for Utility and material handling equipment. - To arrange instruments for plant equipment and accessories. - To review, authorize and to comply all Quality documents. - To ensure statutory compliance of boiler/electrical inspector & standard weights. - To execute modifications in plant as per approved capex and requirement by plant. - To ensure cGMP & EHS compliance. - To arrange the training of department employees for SOP, new system, Qualification etc. - To review maintenance report and energy consumption to ensure corrective action for control of same. - To review annual engineering budget. Preferred candidate profile API & OSD Experience in Regulatory environment , Share CV on Hrd@apotheconpharma.com Perks and benefits Best in Industry
Department : IPR Designation : Officer /Executive / AM / Manager Experience : 2 - 10 years Qualification : MSc (Org. Chem)/M.Pharm Post Graduate Diploma in Patent Management (PGDPM) Location : Vadodara Role & responsibilities To conduct novelty and freedom to operate searches on various databases To prepare patent landscape by analyzing the patent claims and specifications To prepare disclosure of the ROS To retrieve, analyze and interpret the file histories of the patents To assist in patent drafting, filing and prosecution procedures Prepare preliminary reports for identifying new molecules or new opportunities Tracking the competitors patent(s) portfolio and updating the same To assist in drafting of Pre-grant or post-grant opposition(s) To assist in drafting and responding to customer queries To assist in the docket and record management To identify the polymorphism To search on various country patent databases to retrieve equivalent patent information(s), legal status etc.. in different countries. Preferred candidate profile Should be familiar with different patent law(s) particularly IN, USA & Europe Should have good technical skill and knowledge Should be expert in operating SciFinder and other database(s). Perks and benefits Canteen Facility Traspotation Facility Vadodara GMC/GPA/GTL For Social Security
Roles and Responsibilities Collaborate with cross-functional teams to develop intellectual property strategies and plans. Collates information from patent/non-patent literature for designated API for the specified markets Prepares landscape reports for API and evaluates the API vendors route of synthesis against the patents/applications for applicable markets Coordination with API vendors to resolve IP related queries Provides the risk assessment to the Manager for required action. Gives go-ahead to FRD team for use of certain API vendor Periodically monitors patents, updates report and apprises Manager for required action Providing support in litigation matters including conducting invalidity searches, support in discovery and review of related documents Searches and reviews relevant case laws and provides summary / presentation to the team Keeps updated with the current IPR laws and Regulations of the various countries Coordination with client/BD to resolve API IP related queries Ensures compliance to Company policies and values Desired Candidate Profile Experience in Intellectual Property Rights management for APIs Master's degree in Organic Chemistry or related field
Department : IPR Designation : Officer / Executive / AM / Manager - IPR [Formulation] Experience : 02 - 15 years Qualification : M.Pharm (Pharmaceutics) Post Graduate Diploma in Patent Management (PGDPM) Location : Vadodara Role & responsibilities To conduct novelty and freedom to operate searches on various databases; To prepare patent landscape by analyzing the patent claims and specification; To prepare disclosure of the composition or mixture; To retrieve, analyze and interpret the file histories of the patents; To assist in patent drafting, filing and prosecution procedures; To prepare preliminary reports for identifying new formulation or new opportunities; Tracking the competitors patent(s) portfolio and updating the same; To assist in drafting of Pre-grant or Post-grant opposition(s); To assist in drafting and responding to customer queries; To assist in the docket and record management; To identify the polymorphism; To search on various country patent databases to retrieve equivalent patent information(s), legal status etc in different countries. Preferred candidate profile Should be familiar with different patent law(s) particularly IN, USA & Europe; Should have good technical skill and knowledge; Should be expert in operating SciFinder and other database Perks and benefits Canteen Facility Transpotation Facility Vadodara
Role & responsibilities 1. To evaluate and prepare characterization reports for all new product packaging material. 2. Packaging development for different dosage forms like oral solids, liquid, semi-solid, injectable, nasal, device development (support) and other dosage forms for different markets. 3. Preparation and review of Bill of material, Master packing card, and BPR. 4. Comparative evaluation of innovator vs. in house packaging material. Innovator pack reverse engineering at outside lab as per requirement. 5. To prepare compatibility report of packaging material with product. 6. Preparation packaging materials specification and STP. 7. Proof approval for Artwork, Drawing, Shade card, KLD etc. 8. Machine change part development for new packaging material. 9. To search packaging material literature and study to develop suitable packing material for the product. 10. Monitoring of Scale-up and Exhibit batches packaging a. Planning of Scaleup / Exhibit batches. b. Co-ordination with the different departments for execution of large-scale batches 11. To provide technical support to production department in the scale up & exhibit batches at plant and at CMO sites 12. To plan for the exhibit batches packaging and prepare PDR (packaging section). 13. To support regulatory team in response to queries related to packaging. 14. To support packaging material filing and prepare packing development trials protocol and report. 15. To develop new vendors and coordinate vendor development. 16. To provide packaging related support to CFT for product extension to different markets. 17. To prepare and review Technology transfer documentation. 18. To coordinate with cross functional departments like Purchase, Production, RA, QA, Store etc. 19. To be self-updated with the recent updated guidance, literature and industry practices. Preferred candidate profile 1. Preferable Male candidate. 2. Have Pharmaceutical Background in packaging Development 3. Minimum Graduate - Preferably B.Tech [E&C], PGDP
Role & responsibilities To handle the production activities in rotational shift. Controlling manpower in the shifts. Ensuring safety and quality compliance in the shift. Following data integrity strictly at work place & Follow the Instructions as per BMR. Good exposure in Clean room and controlling of foreign particles. Knowledge on QMS document handling & Follow the SOPs during manufacturing process. Handling of different unit operations like Batch charging, Solvent receiving & Charging, Layer separation, Work up, Distillation & Sparkler filtration, Crystallization, Centrifugation, drying, milling, sieving and packing etc. Ensure the cleaning, sanitization as per procedure and recording the document. If any abnormality observed immediately inform to Shift incharge. Critical operations should be ensure Ex. Layer Separation, Work up, Solvent charging & Transfer the reaction mass. Update of Equipment usage log, Weighing balance log & Online documentation of BMR and ECR. Reaction monitoring as per the written procedure given in Batch manufacturing record. Preferred candidate profile Should have exposure to the regulatory requirements of documentation. Adherence to Quality, Safety, Health, and Environment measures and cGMP norms. Please share update cv on email :- hrd@apotheconpharma.com Perks and benefits 5 Lakhs Sum Assured Medical Insurance Canteen Transportation
Exciting opportunity for Quality Control professionals at our USFDA approved facility Company : Apothecon Pharmaceuticals Pvt Ltd Website : www.apotheconpharma.com Location : Dabhasa, Vadodara Experience : For Analyst - 2 - 5 Years) & (Reviewer - 5-15 Years) Department : Quality Control (Analyst & Reviewer) Designation : Officer / Executive / Senior Executives (16 Positions) Role & responsibilities : Analysis as per Planning Online Review in all shifts (Analytical data review) Documentation & GLP Activities Troubleshooting during analysis Must be from USFDA approved facility only Please submit your resume to hrd@apotheconpharma.com or WhatsApp on 6357937184 to be considered for this role. Preferred candidate profile Dynamic work environment Career development opportunities Work-life balance Free transportation & Canteen facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Join our team at Apothecon Pharma and take the first step towards a rewarding career.
Role & responsibilities Exciting opportunity for IPQA Executive at our USFDA approved OSD Manufacturing facility Company : Apothecon Pharmaceuticals Pvt Ltd Website : www.apotheconpharma.com Location : Vadodara Experience : 4 - 9 Years Dept. & Sub Dept. : QA - IPQA - OSD MFG Designation : Executives Collect in-process and Finished sample as per Specifications and Protocol. Check documents like equipment log books, temperature & humidity records. Line clearance of machine & manufacturing area . Checking of batch manufacturing record. Preferred candidate profile Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to hrd@apotheconpharma.com to be considered for this role. Join our team at Apothecon Pharma and take the first step towards a rewarding career.
Quality Control (Wet Lab / HPLC-GC / Reviewer) - Officer to Sr. Executive Education: B.Sc. M.Sc. (Chemistry or related discipline) Job Overview We are seeking skilled and detail-oriented professionals to join our Quality Control (QC) team across multiple functions including Wet Lab Analysis, HPLC/GC, and Analytical Data Review. The ideal candidates should have a strong background in QC testing, regulatory compliance, and documentation practices, with the ability to contribute to continuous improvement in laboratory processes. Key Responsibilities Wet Lab (Officer Senior Officer) Perform routine wet lab analysis and testing of raw materials, intermediates, and finished products. Ensure compliance with QC protocols, SOPs, and regulatory requirements. Maintain accurate documentation and support investigations of deviations, OOS (Out of Specification), and OOT (Out of Trend) results. Perform calibration and maintenance of laboratory instruments. Assist in continuous improvement of QC processes. HPLC GC (Senior Officer Executive) Conduct analysis of raw materials, intermediates, and finished products using HPLC, GC, and other analytical techniques. Ensure compliance with cGMP, SOPs, and regulatory guidelines. Prepare and review analytical documentation, records, and reports. Support method validation, stability studies, and quality investigations. Maintain laboratory instruments and ensure calibration/qualification compliance. QC Reviewer (Executive Sr. Executive) Review analytical test data and reports in compliance with regulatory requirements. Ensure accuracy, completeness, and adherence to SOPs, GLP, and GMP practices. Support investigations, deviations, OOS/OOT results, and recommend corrective measures. Coordinate with cross-functional teams for timely resolution of QC issues. Maintain audit-ready documentation and contribute to continuous improvement in QC processes.
Key Responsibilities: Perform and oversee Quality Control activities in compliance with GLP, GMP, and regulatory guidelines. Conduct analytical testing, review of results, and ensure adherence to internal QC procedures. Review, maintain, and control QC documentation, ensuring accuracy, completeness, and compliance. Ensure timely preparation, issuance, archival, and retrieval of quality records and documents. Support internal and external audits/inspections by providing accurate data and documentation. Investigate deviations, OOS, and non-conformances, ensuring timely closure and preventive actions. Collaborate with cross-functional teams to drive continuous improvement and maintain high-quality standards. Maintain document control systems and ensure adherence to data integrity requirements. Skills & Competencies: Strong knowledge of GLP, GMP, and regulatory compliance. Hands-on experience in analytical testing and QC documentation management. Excellent organizational and record-keeping skills. Ability to handle audits and ensure inspection readiness. Strong communication, teamwork, and problem-solving abilities.
Qualification: B. Pharm Fresher Requirement: Granulation: 2 Nos, Compression: 1 Nos, Capsule Filling: 1 Nos, Coating: 1 Nos. Primary Bottle packing: 1 Nos Experience - 1 to 3 years experience in pharmaceuticals company for handling and maintaining of fully auto mated Glatt integrated line (Horizontal)/Octagonal Blender/Bin Blender/Sifter/Mill Fette Compression machine/Capsule filling machine with line equipment/Automated Tablet and Capsule visual inspection machine/Auto coater machine Countec Bottle filling line. Knowledge of Granulation/Blending, Compression, Capsule filling, Coating and Bottle packing. Must have knowledge of preparation and execution of SOP, manufacturing, Packing and qualification document of SCADA based equipment. Good knowledge of GMP and Communication skill. Online documentation like BMR/BPR in-process checks and Daily documentation QMS understanding is added advantage.
Qualification: Diploma / Pharmacy Fresher Requirement: Granulation: 2 Nos, Compression: 2 Nos, Capsule Filling: 1 Nos, Coating: 1 Nos. Primary Bottle packing: 1 Nos and Secondary Packing: 1 Nos Experience - 0 to 2 years experience in pharmaceuticals company for operation and cleaning of Glatt integrated line (Horizontal)/Octagonal Blender/Bin Blender/Sifter/Mill operation and cleaning Fette Compression machine/Capsule filling machine with line equipment/Automated Tablet and Capsule visual inspection machine/Auto coater machine operation and cleaning Countec Bottle filling line/Track and trace system operation and cleaning. SCADA based machine operation. GMP knowledge and compliance is required, and compliance is required. Online documentation like BMR/BPR and daily documentation. Read and write English.
Job Overview We are seeking an experienced and dedicated Executive / Sr. Executive Peptide Manufacturing to join our team. The ideal candidate should have strong expertise in peptide manufacturing processes, regulatory compliance, and manpower management. The role involves operating advanced equipment, handling commercial-scale processes, maintaining documentation, and ensuring audit readiness. Key Responsibilities Oversee peptide manufacturing processes in compliance with regulatory and quality standards. Handle DAC columns and commercial peptide columns efficiently. Operate and manage commercial lyophilizers for large-scale production. Run and monitor 21 CFRcompliant equipment. Maintain facility as per cGMP and other applicable regulatory requirements. Prepare and review manufacturing-related documents and SOPs. Ensure adherence to safety, quality, and productivity standards. Manage shift-wise manpower, allocate tasks, and ensure smooth operations. Participate actively in regulatory audits and provide necessary documentation support. Skills & Competencies In-depth knowledge of peptide manufacturing and related technologies. Hands-on experience in DAC column handling, lyophilization, and scale-up activities. Strong understanding of cGMP, regulatory compliance, and 21 CFR systems. Ability to prepare, review, and maintain accurate manufacturing documentation. Excellent leadership, team management, and problem-solving skills. Qualification: BE/M.Sc./B.Sc. Chemistry Experience in Peptide manufacturing, knowledge of DAC Column handling, peptide commercial column handling, commercial Lyophilize handling ,
Qualification: Diploma / Pharmacy Fresher Requirement: Granulation: 2 Nos, Compression: 2 Nos, Capsule Filling: 1 Nos, Coating: 1 Nos. Primary Bottle packing: 1 Nos and Secondary Packing: 1 Nos Experience - 0 to 2 years experience in pharmaceuticals company for operation and cleaning of Glatt integrated line (Horizontal)/Octagonal Blender/Bin Blender/Sifter/Mill operation and cleaning Fette Compression machine/Capsule filling machine with line equipment/Automated Tablet and Capsule visual inspection machine/Auto coater machine operation and cleaning Countec Bottle filling line/Track and trace system operation and cleaning. SCADA based machine operation. GMP knowledge and compliance is required, and compliance is required. Online documentation like BMR/BPR and daily documentation. Read and write English.
Qualification: B. Pharm Fresher Requirement: Granulation: 2 Nos, Compression: 1 Nos, Capsule Filling: 1 Nos, Coating: 1 Nos. Primary Bottle packing: 1 Nos Experience - 1 to 3 years experience in pharmaceuticals company for handling and maintaining of fully auto mated Glatt integrated line (Horizontal)/Octagonal Blender/Bin Blender/Sifter/Mill Fette Compression machine/Capsule filling machine with line equipment/Automated Tablet and Capsule visual inspection machine/Auto coater machine Countec Bottle filling line. Knowledge of Granulation/Blending, Compression, Capsule filling, Coating and Bottle packing. Must have knowledge of preparation and execution of SOP, manufacturing, Packing and qualification document of SCADA based equipment. Good knowledge of GMP and Communication skill. Online documentation like BMR/BPR in-process checks and Daily documentation QMS understanding is added advantage.
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