Takeda M Pharma/MSc Chemistry job, Takeda M Pharma/MSc Chemistry vacancy, Takeda announces job opening for the post of QA lead, Chemistry job opening 2023, Check out all the details on the same below:
Job Title: QA Lead – Product Redressing
Locations: IND – Gurgaon
Minimum 2 years practical experience in the testing of drug products especially blood products and possess :
- Post graduate degree in Pharmacy or Science(Chemistry/Microbiology/Biochemistry) or
- Post graduate degree in Medicine – MD (Microbiology/Pathology/Biochemistry) from a recognized University or Institution.
- Preferably Approved as a Technical Analyst by State’s FDA Authority. Minimum 5-6 years’ experience in Pharmaceutical Company in quality function with GMP manufacturing plant environment of Blood Products manufacturing and sterile Pharmaceuticals
- Good knowledge and experience in working on the development, implementation and maintenance of a Quality Management System 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.
Good knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the manufacturing, product release, storage and distribution of pharmaceutical products (including biologics and cold chain).
- Sound knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g., PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.Experience in managing supplier audits, internal audits, regulatory authority inspections.
- Ability to work independently and identify compliance risks and escalate when necessary
- Good sense of urgency and strong follow up Scientific Knowledge
- Ability to manage complex projects and timelines in a matrix team environment.
- Demonstrated interpersonal skills including strong negotiation skills.
- Excellent teamwork and coordination skills
Lead overall Quality Activities including In-process Quality 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
Lead activities to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as per Schedule M of Drugs and Cosmetics Act and Takeda’s global requirements for Redressing Activities.
To resolve quality issues pertaining to redressed products to support the continuous supply of Takeda products in India.
- Implementation,sustainance and governance of Quality Assurance Standards, processes, controls and cGMP in Redressing unit.
- To ensure issuance of BPR.
- To ensure that training for SOP’s, cGMP and On the Job training are imparted to Redressing unit staff.
- To ensure Redressing activities are carried out as per approved Batch Packing Record (BPR).
- To perform IPQC during the Redressing activity.
- Review of Batch Packing Record and Batch Release.
- Maintaining proper documentation and reports.
- Verification of damaged stocks.
- Verification and approvals of Stamp on packing line.
- Verification and approvals of stickers and labels.
- Verification of logbooks.
- Verification of the cleanliness and pest control activity in Redressing unit.
- Verification of the temperature of Packing lines & storage areas of Redressing unit.
- To monitor control sample withdrawal, storage and destruction if required.
- Verification of Calibration and Validation schedule.
- Verification of Preventive Maintenance of facility.
- Qualification of Suppliers and Overall Supplier Management Activities.
- To communicate with customer for any matter related to Redressing Product if required.
- Verification of calibration and validation documents of the Redressing Facility. ·
- Lead activities for Takeda in India to develop, implement and maintain a systematic, effective and efficient local Quality Management System (QMS) as 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.
- The QMS includes but are not limited to documentation creation like Site Master File, Quality Manual, document maintenance & control, Maintenance of logs, SOP writing, personnel training management, Redressed product release, product sample management, product complaint handling, Change Control, Deviation, CAPA ,Gap Assessments.
- Handling of Self Inspections, Takeda Internal Audits and Regulatory Audits by Indian Authorities or any other inspections /Audits.
- Handling of electronic QMS systems like TrackWise, Training systems and electronic documentation management systems.
- Provide support to ensure all KPIs for local quality operation for Takeda India meet the established requirements.
- To execute any other assignment allocated by Head Quality.
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