3 21Cfr Jobs

Role & responsibilities Job Responsibilities knowledge on Quality control function like FP/RM/PM/Stability of Solid dosage forms. good knowledge on QC Instrumentations trouble shooting of QC instruments like Auto titrator, HPLC, GC etc. 21CFR part 11 compliance and Computer system validation Investigation like OOS, OOT, events and deviation management. LEAN management and Good presentation skill exposure to Regulatory Audit handling and management review of SOPs versus practices for gap analysis. Trending of QC data and deriving action plan for compliance readiness Preferred candidate profile B.Pharma / M.Sc with 4 to 6 yrs experience as QC investigator. good in english verbal and written communication, ready to relocate to Jammu Location.

To do planning and scheduling for annual preventive maintenance and calibration of all electrical and instrument installations in the Plant To attend and timely response for all emergency breakdowns of electrical and instrument installations in the plant. To ensure tentative schedule for earthing audit of all electrical installations and its execution, also scheduling & implementations of other GMP requirements. To ensure implementing compliances of computer validation as per 21CFR part 11, GAMP-5 and other relevant guidelines. Ensure the GMP compliance in calibration lab and instrument function. To inspect and approve the electrical and instrumentation items received in Engineering Stores. To evaluate new equipment/facility proposals for Capex & modifications and its procurement with timely execution. Support site project team for evaluation and timely completion of project. To ensure renewal of registrations and licenses related to power & electrical safety from concerned Government Department and for weighing items with Weight & Measurement government authority. To ensure the safety of persons, plant and equipments while carrying out the maintenance job. Work procedure update and training. To critically analyze the expenditure on procurement of items and overall electrical and To do planning and scheduling for annual preventive maintenance and calibration of all electrical and instrument installations in the Plant To attend and timely response for all emergency breakdowns of electrical and instrument installations in the plant. To ensure tentative schedule for earthing audit of all electrical installations and its execution, also scheduling & implementations of other GMP requirements. To ensure implementing compliances of computer validation as per 21CFR part 11, GAMP-5 and other relevant guidelines. Ensure the GMP compliance in calibration lab and instrument function. To inspect and approve the electrical and instrumentation items received in Engineering Stores. To evaluate new equipment/facility proposals for Capex & modifications and its procurement with timely execution. Support site project team for evaluation and timely completion of project. To ensure renewal of registrations and licenses related to power & electrical safety from concerned Government Department and for weighing items with Weight & Measurement government authority. To ensure the safety of persons, plant and equipments while carrying out the maintenance job. Work procedure update and training. To critically analyze the expenditure on procurement of items and overall electrical and instrument maintenance expenditure periodically and find out ways and means to control the same at optimum level. To review the planning and implementation of Energy conservation schemes. Represent as Energy Champion for the site. To ensure timely closer of permanent change control, temporary change control, deviation, CAPA and service calls. Is accountable for the performance and results of a team within own discipline or function. Defines team operating standards and ensures essential procedures are followed based on knowledge of own discipline. To ensure completion of assigned training of self and team members. Exercises limited management authority; sets employee performance objectives, conducts performance reviews and recommends pay actions To ensure all the activities perform in own discipline for self and team should follow the compliance requirement.

Handling of all Vendor Management related activities including qualification of Vendors, Service Providers, Contract Manufacturing and Contract Testing Laboratories across R&D, API and Formulation units of Biological E, pharma divisions. To perform On-site audits as part of vendor audits, contract testing laboratories, contract manufacturing, external service vendors qualifications. Initiation and Review of Quality Management Systems (QMS), including Change controls, Deviations, Investigation reports and CAPAs. To perform Risk assessments related to Vendor, Contract Testing Laboratories and Contract Manufacturing and Service Provider qualification related activities. Preparation & review of Quality agreements & Technical agreements. To provide support / relevant information to the customers / suppliers as per the requirement and to provide remediation plans for the audit observations, if any To schedule, perform the self-inspections and review the Self-Inspection reports and relevant documents as applicable. To facilitate and review the performance of quality system through the review of QMS documents for Management Review Meetings. To co-ordinate for Management Review Meetings. To review and monitor the effectiveness of system changes and adequacy of CAPAs and post closure effectiveness checks. To track the health authorities observations at the Site and R&D and verify the compliance. To coordinate with the team for preparation and implementation of SOPs pertaining to Corporate Quality.