MSc Microbiology Job at Takeda, Apply Online For Ops Lead Role

Job Description

Primary Duties

• Perform Redressing Compliance Activities for Takeda in India to ensure its compliance to Current Good Manufacturing Practices (cGMP) as per Schedule M of Drugs and Cosmetics Act and Takeda’s global requirements for Redressing Activities (Stamping, Stickering and Overprinting) and release of redressed Takeda products.
• Supervise the redressing activities as technical competent person
• To coordinate with supply chain regarding shift scheduling, labels availability, discard of unused labels etc
• Maintaining proper documentation, reports and verification of damaged stocks

Responsibilities

Core responsibilities – 50%

• Implementation of quality assurance standards, processes, controls and cGMP in Redressing unit
• Preparation of operational SOP’s, Master BPR
• To ensure compliance to local Regulatory requirements and Takeda Global Standards
• Support incidence investigation, Deviation & Complaint activities and ensure appropriate CAPA, in consultation w. quality
• CAPA assessment and effectiveness follow-up, in consultation w. quality
• Review and approve appropriate change controls
• Maintaining proper documentation and reports
• To participate internal, external, and regulatory audit
• To communicate and partner with relevant stakeholder (QA, regulatory, commercial) on case-to-case basis

Vendor Management – 50%

• Managing redressing operations (incl. team management) as per Schedule M & Takeda requirements
• Ensure right issuance of BPR by vendor
• Review of Batch packing record and Batch Release
• Facility & equipment maintenance incl. validation & calibration
• Sourcing, selection of sub-vendors for required activities and material e.g. stamps, label printing, equipment & facility validation, calibration etc.
• Oversight on
• Ensure temperature monitoring by vendor in the packing areas as well as in the storage areas
• Calibration and validation schedule adherence
• Plan preventive maintenance of facility
• Verification of damaged stocks
• Verification of Stamp orders and issuance of stamps on packing line
• Verification of logbooks
• Ensure monitoring the cleanliness and pest control activity at the facility
• Managing pollution control, Fire NOCs, and other local statutory requirements
• To ensure repacking activities are carried out by vendor, as per approved BPR
• To ensure that training for SOP’s, cGMP, GWP and On the Job training are imparted to redressing staff

Education and Experience Requirements

Mandatory Requirement

One year practical experience in the manufacture of blood products/ plasma fractionation and possess :

Post graduate degree in Medicine – MD  (Microbiology/Pathology/Bacteriology/Biochemistry/ Immunology) or Post graduate degree in Science(Microbiology) or Post graduate degree in Pharmacy (Microbiology), from a recognized University or Institution.

Minimum 5-6 years experience of pharmaceutical Company in manufacturing operations of  GMP manufacturing and sterile pharmaceuticalsGood knowledge and experience in manufacturing operations (including Blood Products) compliant to local India regulatory requirements on Good Manufacturing Practices (cGMP) and Good Distribution Practice (GDP) and Drugs and Cosmetics Act, Schedule M and WHO guidelines. Basic Understanding of Local Regulatory Environment, preferably with experience of handling regulatory inspections in the past

Key Skills, Abilities, and Competencies

• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
• Execute goals and objectives in a driven and a high performance culture, and as applicable with ability to achieve results with non-direct reports
• Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders
• Able to work with a great degree of autonomy, as part of a global virtual team
• Able to work cross-functionally and cross-culturally, in a global business environment
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
• Able to adapt to changes and positively respond to changes
• Enthusiastic, resilient, dynamic, versatile
• Excellent teamwork and coordination skills

Leadership Behaviors

• Be Positive
• Be Accountable
• Be Results Oriented
• Enhance capabilities

Complexity and Problem Solving

• Strive to drives the business forward and look for practical and compliant solutions to issues.
• Understands total potential impact and contributes significantly to the solution of simple or complex issues arising
• Expected to work with a number of suppliers / products
• Provide a positive and solution oriented environment
• Uses experience to facilitate troubleshooting, and to tackle non-routine work and projects independently
• Offers constructive comments and proposes improvements and rationalizations to systems, policies and procedures
• Uses own judgment to assess what to refer upwards and what to deal independently

Internal and External Contacts

This job needs coordination with Takeda’s internal stakeholders(cross functional team & global quality/Supply chain team), Takeda suppliers, service providers, consultants, business partners, and customers (for product complaint/ recall)

Other Job Requirements

6 days working (Monday to Friday)

Travel on need basis.

APPLY HERE

Hey, since you seem to be curious about the role of Redressing Operations Lead at Takeda, then check out some of the possible interview questions below and the answers.

1. Can you explain your experience with blood product manufacturing and how you have implemented cGMP and regulatory requirements in your previous roles? Answer: Yes, I have worked for over 5 years in the manufacturing operations of GMP compliant sterile pharmaceuticals, including blood products. In my previous roles, I have ensured compliance to local regulatory requirements, Schedule M, WHO guidelines, and Good Distribution Practice (GDP). I have implemented quality assurance standards, processes, controls, and cGMP in the redressing unit. I have prepared operational SOPs and Master BPRs and have supported incidence investigation, deviation, and complaint activities.
2. How have you managed vendor selection and oversight for redressing operations, including stamping, stickering, and overprinting of Takeda products? Answer: I have managed redressing operations as per Schedule M and Takeda requirements, which included team management, review of batch packing record and batch release, and equipment maintenance, validation, and calibration. I have selected sub-vendors for required activities and material sourcing, such as stamps, label printing, and facility validation. I have verified damaged stocks, stamp orders and issuance of stamps on the packing line, and logbooks. I have ensured that training for SOPs, cGMP, GWP, and on-the-job training are imparted to redressing staff.
3. How have you ensured compliance to local regulatory requirements and Takeda global standards in the redressing unit, and how have you participated in internal, external, and regulatory audits? Answer: I have ensured compliance to local regulatory requirements and Takeda global standards by implementing quality assurance standards, processes, controls, and cGMP in the redressing unit. I have prepared operational SOPs and Master BPRs and have reviewed and approved appropriate change controls. I have participated in internal, external, and regulatory audits and have communicated and partnered with relevant stakeholders, such as QA, regulatory, and commercial teams, on a case-by-case basis.
4. Can you explain your technical competence in supervising redressing activities, including stamping, stickering, and overprinting of Takeda products, and how you have coordinated with the supply chain regarding shift scheduling, label availability, and discard of unused labels? Answer: Yes, I have supervised redressing activities as a technical competent person, which included stamping, stickering, and overprinting of Takeda products. I have coordinated with the supply chain regarding shift scheduling, label availability, and discard of unused labels. I have ensured temperature monitoring by the vendor in the packing areas as well as in the storage areas, calibration and validation schedule adherence, and plan preventive maintenance of the facility.
5. Can you describe your leadership skills, including your ability to build authentic relationships, engender trust, cooperate as a team leader or team member, and execute goals and objectives in a driven and high-performance culture? Answer: Yes, I have strong interpersonal skills, including the ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information, and deliver results with a team. I execute goals and objectives in a driven and high-performance culture, and as applicable, with the ability to achieve results with non-direct reports. I have organization agility and the ability to apply that capability to lead change, deliver strong results, and build the confidence of stakeholders. I can work with a great degree of autonomy, as part of a global virtual team, and can work cross-functionally and cross-culturally in a global business environment.

Editor’s Note: MSc Microbiology Job at Takeda, Apply Online For Ops Lead Role. MSc Microbiology Job at Takeda. Please ensure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.