Department:QC INSULIN
Position: Executive (14221)
Experience:05-07 Years
Responsibilities:
1. Product specifications, cGMP (current good manufacturing practice), cGLP (current good laboratory practice), self-inspection, adherence to quality policies, and EHS policies.
2. Raw material tracking and handling, including receiving samples of packing materials and consumables.
3. Vendor samples, packing materials, consumables, testing, and reporting of raw materials.
4. Carrying out calibration of analytical instruments, temperature mapping, periodic qualification, instrument qualification, etc.,
5. Monitoring analytical instrument preventive maintenance and working with a cross-functional team on it.
6. Creation and upkeep of quality documentation.
7. Standard and chemical preparation, storage, and upkeep.
8. QC protocol preparation, updating, and implementation; evaluation of new vendor samples.
9. Monitoring and sending samples for testing in accordance with protocol to outside labs as well as other laboratories on the site.
10. Preparations of protocol, reports and maintenance.
Department:QC INSULIN
Position: Junior Associate (14457)
Experience:00-01 Years
Location:Malaysia
Responsibilities:
1. To keep an eye on adherence to Good Manufacturing Practice requirements
2. To guarantee that all production-related instructions are properly followed.
3. To update the DSP2 real-time data input in the documents BMR, CKL, LS, ECC, and other.
4. To carry out equipment validation and qualification procedures.
5. To carry out and record procedures in compliance with cGMP.
6. Production equipment maintenance carried out in tandem with the maintenance department
7. Adhering to EHS guidelines and protocols8 In charge of carrying out all OTIF tasks pertaining to downstream purification
Good Documentation Practices (GDPs) and ALCOA Plus Principles for Data Integrity in Pharmaceutical
Department:Insulin Instrumentation
Position: Executive (14221)
Experience:01-04 Years
Responsibilities:
1. Responding quickly to issues with SFP upstream, PHI, PHI-E, PHI-Annexure, and related water facilities.
2. Regularly calibrating online pH, conductivity, and dissolved oxygen measuring systems deployed in upstream and downstream insulation manufacturing facilities.
3. Preventive maintenance operations pertaining to instrumentation for process equipment are planned, carried out, and the corresponding check list is updated.
4. Notifying the appropriate Plant Head or Instrumentation Head of any updates to crucial breakdown facts.
5. Resolving instrument complaints made in SAP and terminating the alert upon completion of the task.
6. Strict observance of GEP, EHS, and cGMP rules during activity execution.
7. To adhere to the company's EHS rules and procedures as set forth.
8. Creating the material request in SAP for spares usage during shift maintenance activities and preventive maintenance.
9. Generating the shift report in SAP.
Creating Tomorrow: The Rise of Generative AI in Art, Design, and Beyond
Department: QA GENERIC
Position: Deputy Manager (14371)
Experience:08-12 Years
Responsibilities:
1. Setting up and keeping up an effective QMS in accordance with global quality standards, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
2. Making certain that every process and operation complies with the regulatory standards established by relevant authorities and organizations such as the FDA and EMA.
3. Overseeing the production, inspection, and management of high-quality documentation to guarantee conformity to standards, correctness, and completeness.
4. Examine and apply modifications to procedures, systems, or goods in a methodical and controlled way.
5. Recognizing and evaluating risks in high-quality procedures and goods, as well as creating plans to reduce such risks in order to protect patient safety and product excellence.
6. Taking the lead in projects to improve quality procedures, boost productivity, and promote a continuous improvement culture throughout the organization.
7. Working with cross-functional teams, educating staff members about quality procedures, and making sure they understand and follow QMS guidelines.
8. Performing in-depth investigations to determine the underlying causes and contributing elements of quality-related incidents, OOS, OOT, deviations, non-conformances, and complaints
9. Creating and executing efficient CAPA plans based on the results of investigations to deal with the underlying causes and stop quality events from happening again.
10. Finding patterns, reoccurring problems, and chances to improve quality systems and processes in order to support the QMS's ongoing progress.
11. Ensuring that the organogram, quality manual, and site master file are prepared.
12. Preparing and reviewing the product's APQR and starting any necessary modifications in accordance with the recommendations made at the conclusion.
13. In charge of managing CAPA management, deviations, risk assessment, and change controls.
14. In charge of reviewing and approving CAPA, deviations, change controls, etc.
15. Managing product recalls and returns, market complaints, and failure investigations.
16. Trend analysis of quality system parameters preparation and evaluation.
17. Performing internal audits on time and making sure that action plans for compliance are in place in response to identified problems
18. Planning, carrying out, evaluating, and recording the Management Review Meeting Report
19. Managing regulatory and customer audits and promptly responding to the findings
20. In charge of overseeing audit compliance and validating the efficiency of CAPA implementation.
21. To guarantee that all Master papers, including Operating Instructions, BMR, BPR, Validation Protocols/reports, Hold Time Study Protocols/reports, Stability Protocols, Standard Operating Procedures, etc., are properly reviewed and approved in a timely manner.
22. In charge of looking at OOT trend results and out-of-specs outcomes in microbiology and QC.
23. In charge of looking into occurrences in the microbiological and quality control lab.
24. In charge of reviewing and approving protocol and reports on method transfers and validations of analytical techniques.
Department:INSULIN PRODUCTION DOWNSTREAM
Position: Associate Manager (13933)
Experience:03-10 Years
Responsibilities:
Adherence to standard operating procedures and product specifications.
Coordinate with operation teams for operation excellence and process improvements
Responsible for review of all documents for execution of projects from URS to PQ for upstream and downstream.
Evaluation and implementation of ideas generated by the team.
Responsible for periodic requalification of all equipment in the manufacturing facility as per planner.
To ensure department documentation compliance (All type of investigations) with the help of given resources as per the set procedures for upstream and downstream. Provide support in troubleshooting activities related to the plant and process and arrive at effective CAPA.
Responsible to prepare and support for all qualification activities pertaining to modification/refurbishment carried out in the SFP and PI.
Planning and Co-ordination for in house projects & CAPEX.
Steering the team to achieve the set production targets successfully.
Training and troubleshooting on Process automation systems.
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A global leader As we search for cutting-edge ways to improve patient outcomes now in order to create a brighter future, we continue to use the pioneering spirit that paved the way for biotechnology in India. This spurs us to continuously investigate new methods for treating cancer, diabetes, and autoimmune diseases. Through our pharmaceuticals, millions of patients are given access to life-saving care and relief in more than 120 countries, and our research and development is focused on prevention, alleviation, and treatment. Our aim is to attain health parity. With the aid of state-of-the-art therapeutic platforms, our 13,500+ employees blend compassion, science, and creativity to solve problems in healthcare. Our four global businesses are biologics that are novel, biosimilars, research services, and generics.
They are indicative of Biocon's risk-aware approach, which is bolstered by adaptable network connections, a robust pipeline, and a timely "developing markets" emphasis. We have leveraged India's value advantage of unparalleled scientific competence and cost-competitive manufacturing to achieve size, speed, and quality. By enabling more patient access to pharmaceuticals globally, we want to create health equity. Our goal is to provide an affordable specialist pharmaceutical portfolio to all individuals, regardless of location. We are still investing in the development of novel therapies for cancer, diabetes, and immunology. Our scale economies and global reach are expanding.