Job location:  Taloja -Navi Mumbai

Experience Required: 15-20 years of experience

About M. J. Biopharm

With a rich heritage of more than 20 years, MJ Biopharm is a biopharmaceutical company that produces medical formulations for combating a plethora of ailments. MJ Biopharm is a reliable name for life-saving products against diseases such as Diabetes, Cardiovascular, NSAIDS and antibiotics.

Over the years, MJ Biopharm’s core innovation and focus has been channelized in manufacturing of biosimilars & biopharmaceuticals formulations. Currently, MJ Biopharm’s pharmaceutical formulations are accredited & sold in more than 30 countries globally

Job Responsibilities :-

1. Responsible for preparing production plan in consultation with PPIC department and execution thereof with effective planning and utilization of Men, Materials and Machineries for quality linked productivity.
2. To approve the instructions relating to production operations and to ensure their strict implementation.
3. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
4. To ensure that the production records are evaluated and signed by an authorized person.
5. Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc.
6. Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities.
7. To ensure the qualification and maintenance of department, premises and equipment.
8. Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR).
9. To ensure that the appropriate validations are done.
10. Ensure and manage manufacturing activities.
11. Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same.
12. Ensure appropriate inventory of Consumable in the Department for smooth functioning.
13. Responsible for Co-ordination with Technical Services, Quality Assurance / Quality Control, Finance, Purchase, Warehouse and Administration Departments for effective management of Production targets.
14. Ensure wastage control and optimization of yield at various stages of manufacturing and packaging operations.
15. Ensure compliance to various In-process control guidelines provided in the batch documents.
16. Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance.
17. Ensure that personnelfollow basic safety guidelines during operations.
18. Responsible for the preparation of training calendar for employees and to ensure that the required initial and continuing training of department personnel is carried out and adapted according to need on cGMP and various operational activities.
19. Responsible for preparation of accurate and timely reports of various production activities showing performance and shortcomings against agreed/planned parameters (monthly presentation, work in progress (WIP) statement yield report, monthly planning, expense budget stationary, housekeeping material,production item &capital budgetetc).

• Interested Applicant Can send their CVs on shital@mjbiopharm.com or vnagare@mjbiopharm.com

Job location:  Taloja -Navi Mumbai

Experience Required: 12-15 years of experience

About M. J. Biopharm

With a rich heritage of more than 20 years, MJ Biopharm is a biopharmaceutical company that produces medical formulations for combating a plethora of ailments. MJ Biopharm is a reliable name for life-saving products against diseases such as Diabetes, Cardiovascular, NSAIDS and antibiotics.

Over the years, MJ Biopharm’s core innovation and focus has been channelized in manufacturing of biosimilars & biopharmaceuticals formulations. Currently, MJ Biopharm’s pharmaceutical formulations are accredited & sold in more than 30 countries globally

Job Responsibilities :-

1. To lead quality control department of liquid Injectables and dry powder Injectables laboratory.
2. To plan, distribute and monitor the Raw material, In-process, finished product, stability samples and other miscellaneous samples in quality control department.
3. To maintain laboratory as per regulatory and cGMP compliance.
4. Troubleshooting of errors identified during routine job work.
5. To review SOP’s, Qualification and Validation documents, Study Protocols and Reports, Quality Management System (QMS) documents and other documents as per requirement in quality control department.
6. To ensure all activities in quality control department are inline as per SOP and predefined parameters and all necessary testing is carried out and the associated records evaluated.
7. To lead quality control department during regulatory and vendors audit. To give compliance to observation found during audits.
8. To train the company employees and contact persons as per defined procedure and cGMP requirements.
9. To participate in Calibration and Qualification activities of Instruments and Equipments.
10. To perform analysis of microbiological tests as per requirement.
11. To perform Internal and Vendor Audits.
12. To approve or reject, starting materials, intermediate, bulk and finished products.
13. To approve specifications, sampling instructions, test methods and other Quality Control procedures.
14. To ensure the qualification and maintenance of quality control department, premises and equipments.
15. To ensure timely and effective communication to raise quality issues to the appropriate levels of management.

• Interested Applicant can send their CVs on shital@mjbiopharm.com or vnagare@mjbiopharm.com

Job location:  Taloja -Navi Mumbai

Experience Required: 10-12 years of experience

About M. J. Biopharm

With a rich heritage of more than 20 years, MJ Biopharm is a biopharmaceutical company that produces medical formulations for combating a plethora of ailments. MJ Biopharm is a reliable name for life-saving products against diseases such as Diabetes, Cardiovascular, NSAIDS and antibiotics.

Over the years, MJ Biopharm’s core innovation and focus has been channelized in manufacturing of biosimilars & biopharmaceuticals formulations. Currently, MJ Biopharm’s pharmaceutical formulations are accredited & sold in more than 30 countries globally

Job Responsibilities :-

1. Preparation and review of validation protocols, reports, apex documents, and departmental SOPs.
2. To ensure that product are manufactured in compliance with cGMP requirement.
3. To monitor, track & arrange for the equipment, utility, process, cleaning, vendor and other qualification/validation related activities.
4. Monitoring of validation activities.
5. Prepare and review of validation master plan.
6. Reviews of executed validation document for equipments, media fill, utility, HVAC, water system.
7. Review of executed BMR, Media fill.
8. Prepare & review of standard operating procedure related validation.
9. Responsible for Inspections from regulatory agencies, consultants, service agencies etc. for factory premises.
10. Ensure the final checking of the finish product before releasing the batch.
11. To ensure that the product are correctly processed and checked according to define procedure.
12. Co-ordination is made for the manufacturer, supply and use of the correct starting and packing materials.
13. Review of validation master documents.
14. To check the effectiveness and applicability of the quality assurance system as per the instruction of HOD QA.
15. To prepare and review the SOP for QA department and other SOP originating from QA and to review the SOP of all departments.
16. Review of the BMR / BPR Filled by the Production before final release of the product and final checking of the finished product before releasing the batch for dispatch.
17. To monitor and review annual product quality review report for the product.
18. To review the Qualification / Validation protocols / report for equipment qualification / process validation / cleaning validation.
19. To review the calibration certificate / report.
20. Approve reviewing training activities; and imparting in–house training.
21. To carry out all such duties that assigned by HOD QA from time to time upon requirement from management.
22. Responsible to conduct on job and departmental trainings to QA Personnel.

• Interested Applicant can send their CVs on shital@mjbiopharm.com or vnagare@mjbiopharm.com