321 Injectables Jobs - Page 8

Biological E. Limited (BE) invites both experienced professionals and fresh diploma holders, as well as graduates and self-driven individuals, to join its Specialty Injectables Business located in Shamirpet, Hyderabad. The available positions are listed below: Injectables QUALITY ASSURANCE : Designation : Executive & Senior Executive Qualification : B. Pharm / M. Pharm / M.Sc. Experience : 3-9 Years Role : IPQA (In process QA Injectables) PRODUCTION PHARMA: Designation : Officer & Senior Officer Qualification : Diploma / B. Sc. Experience : 2-6 Years Role : Filling/Autoclave/Compounding/Lyo PRODUCTION PHARMA: Designation : Executive & Senior Executive Qualification : M. Pharmacy / B. Pharmacy/M.Sc Experience : 2-10 Years Role : Filling/Autoclave/Compounding/Lyo Quality Control: Designation : Executive Qualification : B. Pharm / M.Sc. Experience : 3-6 Years (Injectables) Role : RM/FG/Stability Microbiology: Designation : Executive Qualification : M.Sc (Microbiology/Biotechnology) Experience : 3-6 Years Role : Testing /EM Interested Candidates may Walk-in with an updated Resume, latest increment letter, and payslips for the last 3 months on Sunday, Jun 22, 2025 from 09:00 am to 01:00 pm at Hotel Grace Majestic, Beside Mathany Saldanha Administrative Complex, Ambaji Road, Fatorda, Margao - Goa 403602. Candidates with relevant pharmaceutical experience may walk-in for the interview.

Greetings From Immacule Lifesciences Pvt Ltd! We are conducting Mega Walk-In Drive for both OSD & Sterile Injectable Manufacturing on Sunday (22/06/25). Requirements: Positions : Officer to Assistant Manager Experience : 2 - 10 Years in Pharma Industry Job Location : Nalagarh, Baddi Departments: Production & Packaging OSD : ( Granulation, Compression, Coating, Capsule, Blister, Alu - Alu, Strip, AutoCartonator) Sterile : Manufacturing, Filling & Sealing, Autoclave, CNC, Vial Washing, Tunnel, Lyophilization Quality Control OSD & Sterile : Instrumental and chemical analysis i.e RM/PM/FG/ Validation/ Micro/ Stability and having competency on instruments like HPLC, GC. Quality Assurance OSD &Sterile : IPQA/QMS/Validation/Qualification/Documentation/Audit Compliance/Training/Vendor Qualification/Micro Compliance/Media Fill/PV/CV/ APQR with thorough knowledge of cGMP norms. Engineering: Sterile : Process Equipment's like Vial Washing, Vail Filling, Tunnel, Autoclave, HVAC, BMS & EMS Boiler & Water System. OSD : Plant Maintenance, HVAC, Utilities & Water System Candidates who are not able to attached the Walk-In drive, please send your resume to hr@acmegenerics.in / career@acmeformulation.com

Role & responsibilities • You will be responsible for coordinating with cross functional teams for ensuring that preventive maintenance is carried out as per schedules in SAP. • Your role involves preparing the PMP (Preventive Maintenance Plan) and maintaining the necessary records of breakdowns and maintenance activities in the PMP as per defined frequency. • Your responsibilities include handling of external contractors and agencies, reviewing and ensuring implementation of the instructions (Work Instructions and SOPs Standard Operating Procedures) related to production operation. • You will train and assist the team members during troubleshoot and breakdown of machines and commissioning of new Equipment. • You will ensure balance investigation and inventory control for all instrument spares parts. • Your role involves planning, consolidating and submitting the maintenance budget for the allotted area/unit. • You will ensure that the maintenance expense is within the budgeted amount. • You will be responsible for ensuring availability of all process equipment and regular maintenance of all process equipment spares by following up with OEMs (Original Equipment Manufacturers), external vendors and SCM (Supply Chain Management). • You will be accountable for enduring closure and completion all assigned CAPA (Corrective and Preventive Actions) on time. • You will be expected to support any technical/documentation activities at site as per instructions from Section Head. • You will be responsible for preparing, updating, and maintaining all necessary documents for audits like SOPs, formats, PM (Preventive Maintenance) books, protocols, and Machine History Books for the respective areas. • Your responsibilities include facility upkeep of respective areas as per GMP (Good Manufacturing Practices) and cGMP (Current GMP). • You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Preferred candidate profile Should Have Experience in Injectables(Preferable), OSD

Responsibilities: * Develop analytical methods for injectables using HPLC & GC. * Conduct method transfers, stability studies, & dissolution tests. * Validate methods through analysis & injection experiments. Health insurance Provident fund

Candidate should be B.Pharmacy/M.Pharmacy with 6 to 8 years of experience in Injectable Manufacturing from a reputed pharma company with regulated markets like US & Europe. Manage production activities for injectable products, ensuring compliance with regulatory requirements and quality standards. Oversee shift operations, including planning, execution, and monitoring of production processes. Ensure timely completion of batches within budgeted timeframes while maintaining high-quality output. Candidate should have Maharastra State FDA approval certificate.

To offer consultation & patient diagnosis, perform/supervise all medical procedures of Dermat Led services ensuring efficacy, safety & high professional standards of medical procedures carried out under your supervision. Required Candidate profile Consultation & Patient Diagnosis Perform doctor led services Candidate must be MD or DVD or DDV or DNB in Dermatology Lucrative incentive will also be given CONTACT-Ishan/Neetu 9910796268/7838473883 Perks and benefits Leaves & Incentives as per company policy

About Company VEA IMPEX is engaged in the export of pharmaceutical products, including branded generics and specialty products, to global markets. With over one and a half decades of experience, we have established strong relationships with our suppliers and continue to build new alliances. We are dedicated to continuous learning and growth in the distribution industry. Link: https://veaimpex.co.in/ Job Description: Were hiring a Business Development Executive to generate sales leads, handle outbound calls/emails/chats, build client relationships, and promote our pharmaceutical products in global markets. The role includes achieving sales targets, identifying new customers, and supporting marketing efforts. Key Skills: Business development & sales Pharma industry knowledge Excellent communication & negotiation skills Export/Distribution experience (preferred) Self-motivated, target-driven

Excellent scope for both (Fresher & Experienced Dermatologist) to offer client consultation, supervise and execute advanced skin & hair cosmetic procedures at the clinic. Responsibilities & Duties: Consult with and treat patients at the designated clinic, perform all dermatology-led medical procedures, and supervise non-dermatology-led procedures. Ensure the efficacy, safety, and adherence to high professional standards for all medical procedures performed under your supervision. Deliver treatments of the highest quality, following established SOPs and company guidelines. Strive for high client satisfaction in all consultations and treatments, as reflected by client feedback and evaluations from the Area Medical Head (AMH) and Area Operations Manager (AOM). Required Candidate profile: MBBS and Masters (MDDVL), Diploma (DDVL, DVD) or Doctorate (DNB) in Dermatology. Strong knowledge and experience in medicine and dermatology. Excellent communication skills and Energy Levels. Ability to connect well with clients. For more details contact 9908974287 or amulya.doni@olivaclinic.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

• Communicate and collaborate with subordinates on goals. • Ensure complete strategy/system implementations as per directives • Induct new employee as per companys policy, ensuring no deviation while practicing policies and code of conduct • Guide team members to resolve issues, dealing with stockist & chemist. • Prepare and submit the tour programme for self and team as per the guidelines • Monthly analysis of Primary/ Secondary sales, customer coverage etc • Build business relationships with key customers • Brief sub-ordinates on the incentive scheme • Ensure Annual target Achievement of all HQ • Ensure achievement of all New Launches If Interested and have relevant experience, requesting you to share your CVs on : narendra.nathani@zuventus.com

Role & responsibilities Job description Dosage forms experience: Solid Oral & Injectable experience in TTD/PDL/MS&T. Perform formulation development activities on differentiated formulations and innovative technologies as part of product development in R&D and in Pilot/Manufacturing Site. Follow good laboratory practices, good documentation practices (LNB writing) and maintain the logbooks and forms for equipment/instruments. Dedicate Experience in technology transfer of product(s) under development activities from scale up, exhibit batches. To lead and support the site transfer products from scale up to product launch. To prepare, review and hand-over the Technology Transfer Dossier to plant and communicating effectively to CFT team :- MFR, MPR, BMR, BPR, Preliminary Risk assessment (as per QbD) Risk Assessment of before going to Scaleup Risk Assessment of before going to Exhibit batches Scaleup Protocol & reports Scaleup Sampling and Exhibit batch sampling Plan Exhibit batch reports Control Strategy (Qbd) before Scaleup, Exhibit batches Risk assessment of CPP over CQAs and etc. And not limited to. To provide the technical inputs for initiation of Scale up batches. To provide the technical presentation on new product initiation to Cross functional team. To monitoring and execution of Scale up batches for site transfer products as well as in-house developed products. To co-ordinate with cross functional teams for smooth technology transfer. To review the exhibit batch documents, intended documents for filing purpose. Qualifications M.Pharm or Ph.D. in Pharmacy with minimum industrial experience of 4 to 9 years in technology transfer solid oral formulations and injectable products.

Immediately hiring for reputed Pharma Industry @Silvassa Post: Microbiologist Qual: BSc/MSc in Micro Exp: Min 1Yrs Salary: As per candidates Ms. Shiva 9408863300 hr.asst@creativehr.in

* For Quality Control (IPPT/FP, RM/PM):- To perform all test for in process product & finish product as per the specification and schedule. To investigate failure of FP / Out of specifications (OOS) and take the corrective and preventive actions (CAPA). To perform and ensure the calibration of instruments as per the schedule. To perform and ensure preparation of reagent / volumetric solution as per schedule. To perform and ensure observation of FP retained samples. To ensure that all documents related to the testing data and related papers are maintained properly. To implement Corrective and Preventive Action (CAPA). To carry out the sampling of all the materials according to Standard Operating Procedure (SOP). To carry out the testing of Raw Material and Packing Material according to approved procedure. To release Raw Material and Packing Material. To carry out the calibration of instruments as per the schedule. To prepare the working standards as per the guidelines and various pharmacopoeias. To ensure the status tag on the released material and transfer such material in the released area. To follow the Good Laboratory practices and Good Manufacturing practices (GMP). To prepare requirement list of chemical & reagent for procurement. To perform the analysis of stability sample as per current specification. To compile the data required for internal quality audit in the plant, as and when required. * For Quality Control (Stability):- To implement the change in procedure as per change control note. To check and verify the sampling of respective samples as per defined intervals for testing. To check and verify that the samples are kept at appropriate temperature and humidity as per defined procedure, which is as per the Standard Operating Procedure. To verify results of analysis conducted in respective period, and to carry out trend analysis. To coordinate with Purchase department for routine requirement and follow up for the procurement. To sign the documents related to stability studies data. To select product batches for the stability studies. In the absence of Officer, Executive will ensure his roles and responsibilities. In the absence of Executive, Sub-department Manager will ensure these roles and responsibilities. To file deviation in case of non-compliance * For Quality Control (Micro):- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines. To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, chlorides, hardness, silt density index and other testing as per the requirements. To analyze the samples of water system after maintenance work . To observe and record the results the microbiological plates and test tubes after analysis as well as supervise discarding method of same. To perform the timely microbiological testing of finished product samples, pre-sterile samples, Raw material as well as Packing material sample as per the requirements and SOPs and record the results for the same. Candidate Profile:- Ready to work in Rotational shifts. Excellent understanding about working area. Initiator and Learner. Decision making ability. Team player and if required, can provide training to other team members. Good communication. The above mentioned requirement is for Male Candidate Only. Hence can be ready to work in rotational Shift. Candidate having Parenteral /Injectable exposure would be preferable . Candidates having Pharma exposure will only be considered for interview process. Fresher can also email their CV on Anee.Silas@otsukapharma.in

Qualification: Bsc Chemistry/Bpharma Experience : 0 to 5 Years CTC: Up to 4.5 LPA Work Location : Ankleshwar Experince in Pharma Company Prefer Like OSD, Tables, API send cv on sdpbharuch@gmail.com with Sub : Production Ankleshwar Required Candidate profile Interview Venue: SDP HR SOLUTION 610, GOLDEN SQUARE BESIDE DMART ABC CIRCLE BHARUCH Share CV on sdpbharuch@gmail.com with Subject: Production Ankleshwar No Charges Share with Friends & Colleagues

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at N-32, Additional Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

The reputed pharmaceutical company engaged in development, manufacturing and marketing of oral solid dosages forms in regulated market. We are looking for competent, growth-oriented professional in Quality Assurance and Quality Control profiles for our USFDA & EU-GMP approved OSD manufacturing facility at Patalganga MIDC, Tal.- Panvel, Dist.- Raigad.Roles and Responsibilities Ensure compliance with cGMP guidelines during formulation development, solid oral manufacturing, and OSD production. Conduct analytical method validation, stability studies, and quality control activities to ensure product quality. Develop and maintain documentation for batch records, test results, and equipment calibration schedules. Collaborate with cross-functional teams to resolve issues related to process deviations and CAPAs (Corrective Action Preventive Actions). Participate in audits conducted by regulatory agencies such as USFDA. Desired Candidate Profile 3-7 years of experience in pharmaceutical industry with expertise in formulation development, solid orals, OSDs, QC/QA/Qc/quality assurance/quality control. Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from a recognized institution. Strong understanding of GMP regulations and industry standards for pharmaceutical manufacturing.

Alembic Pharmaceuticals Ltd. is looking for Research Scientist/ Senior Research Scientist- Analytical Development Advanced characterization Laboratory (Peptides and Complex Generics) based at our Injectable R&D Vadodara Role & responsibilities : 1) Develop and validate analytical methods for various aspects of peptide and complex injectable formulations, including purity, identity, degradation products and stability. 2) Expertise in relevant techniques like HPLC, LC-MS, UV/Vis Spectrophotometry, GC, Particle size, In vitro release etc. 3) Data analysis and interpretation, prepare analytical protocols, reports and contribute to regulatory submissions. 4) Identify and resolve analytical issues, ensuring method accuracy and reliability. 5) Ensuring compliance with cGMP and GLP. 6) Exposure of characterization study for peptide and complex injectable formulation as per product specific regulatory guidelines. Interested Candidates may share their CV to msnt@alembic.co.in with position title "ARD"

Egg Handling Pre-incubation Egg Candling Allantoic Fluids/Embryo Harvesting Inactivation Aseptic Handling and Sampling cGMP Practices Documentation

PRODUCTION BULK MANUFACTURING (DRUG SUBSTANCE / ANTIGENS) Designation: Assistant Manager/ Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI Desired Experience: Applicants with relevant experience in Vaccine, Biosimilars or Injectable Manufacturing will be considered. To perform Upstream and Downstream activities of bacterial or Viral antigens Execution of upstream and Downstream production batches. Focus on timely execution, to ensure that the process is carried out as per cGMP compliance and batch timelines Execution of documentation activities of liaison with QA and QC as per cGMP compliance. PRODUCTION FORMULATIONS (Injectables) Designation: Sr. Executive/Executive/Sr. Officer/Officer Qualification: M.Sc. (Lifesciences) / B. Pharmacy / Diploma / B.Sc. / ITI BLENDING: Ability to handle shift plans for formulation activities. Operate and maintain equipment like autoclave, blending vessels. Ability to handle and maintain equipment like autoclave, blending vessels, CIP and SIP skids. FILLING: Ability to handle shift plans for filling activities. Operate and maintain equipment like Vial washing, Tunnel Sterilizer, Filling and Capping. PACKING & LABELING: Ability to handle shift plans for Vial labeling Machine & VVM dot Machines with Inspection system. Operation of Videojet and Control print Printer for Batch Coding. Operation of Track & Trace System, monitoring of Cold room and Deep freezers temperatures. Engineering (Biologic/Injectables): Designation: Sr. Executive/ Executive/Sr. Officer/Officer Qualification: B Tech / Diploma Process Equipment's: Experience in Breakdowns and preventive maintenance of Vial Washing, Filling, Capping, Autoclave and Labelling Machines, Jacketed Vessels, lyophilization, Ability to handle shift operations. Instrumentation: Ability to handle shift operations for Instrumentation activities like BMS, Breakdown maintenance, Preventive Maintenance, Calibration, AMC and Interim projects, Reviewing the completion of breakdown status / Calibration / PM works, Handling basic troubleshooting in PLC (Programmable Logic Controllers) and SCADA (Supervisory Control & Data Acquisition). Quality Control (Biologics/Vaccines): Designation: Asst. Manager/Sr. Executive/Executive Qualification: M.Sc. (Lifesciences) / B. Tech/M. Tech (Biotechnology) Job Roles: Biochemical Assays: - Involved in the estimation of total and free components in polysaccharides, along with biochemical analyses such as protein, nucleic acid, aluminium content, and composition analysis. Experience in analytical method validation, adherence to ALCOA principles, and management of OOS and OOT investigations. Instrumentation Testing: - Hands-on experience in handling analytical instruments such as HPLC and IC, along with performing instrument-based assays including molecular size, aggregates, purity, and composition analysis. Basic troubleshooting, 21 CFR Part 11 and Audit trial review practices, ALCOA principles, OOS, OOT systems and investigations. Virology: Experience in in-vitro viral testing of Starting material, Raw material, In-process, Final bulk, Final lot and Stability samples for Viral vaccines. review testing for QC release of products/RM/stability studies of Viral Vaccines/New projects/Products QA In Process Designation: Deputy Manager / Asst. Manager/Sr. Executive/Executive Qualification: M. Pharmacy/M.Sc./ B. Pharmacy Drug Substance: To execute IPQA activities for Bulk Viral Antigen production, including ensuring GMP compliance on the shop floor, line clearance, dispensing, and preparation processes. review and approval of batch records, SOPs, PV, CV, and APS documents; QMS management; trending and batch release activities; control and reconciliation of Master and Working Cell Banks Drug Product: To execute IPQA Fill-Finish activities. including the review of SOPs, batch records, executed validations and media fills; line clearance for formulation and filling operations; and the management of change controls, deviations, OOS investigations, and trend analysis. QMS: Oversight of QMS activities, including change control, deviations, OOS, OOT, CAPA, and self-inspections, as well as conducting compliance walkthroughs and Gemba walks. Responsibilities also include trending and review of QMS metrics, support for regulatory inspection management, and the management of the Site Master File, gap assessments, and quality risk assessments.

Role & responsibilities Manage and oversee work orders for syringe processing lines, ensuring efficient execution of production plans to maximize machine performance. Plan and implement batch production on a product-specific basis, optimizing throughput and minimizing downtime. Collaborate with cross-functional departments to ensure uninterrupted operations and timely execution of preventive maintenance schedules. Lead initiatives to reduce market complaints, aiming to maintain a production ratio of over 20 million units per justified complaint. Review BMR for new products to be processed on syringe lines. Review and approve BMRs for new products prior to processing and verify completed BMRs for submission to Quality Assurance. Develop, review, and implement SOPs for syringe processing operations, ensuring thorough training and compliance among line operators. Monitor and enhance line yield while working to minimize rejection rates through process improvements and quality control measures. Ensure timely preparation of customer samples as per specifications, with accurate documentation in BMRs and logbooks. Oversee SAP activities related to batch processing, including data entry, reconciliation, and return of unused materials to inventory.. Ensure optimal shift-wise performance of SPRC machines, maintaining complete and accurate documentation in SAP, BMRs, and logbooks. Prioritize and coordinate the ETO process of completed batches, ensuring all related entries are updated in both BMRs and SAP. Maintain audit readiness by ensuring no critical observations in the production area through strict compliance and monitoring. Ensure NVPC records are correctly attached to the respective BMRs and submitted to QA within the designated timeline. Lead training programs for staff and operators on cleanroom protocols and enforce adherence to cGMP standards. Ensure full compliance with the most recent EHS guidelines across all production activities. Drive continuous improvement of the EHS management system through effective implementation, monitoring, and periodic review. Preferred candidate profile Education Qualification Mpharm /Bpharm /BSc /Msc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited institution. Experience Experience: 8-12 years of experience in sterile injectable/aseptic pharmaceutical manufacturing (preferably in processing functions).