Job Information
Sun Pharmaceuticals, Inc Manager Batch Certification in India
POSITION SUMMARY
Manage overall batch certification review of QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles).
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
Lead the review of all QC records related to Batch certification program.
Review Deviations, CAPAs, OOS/OOT investigations,
Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
Review initiated CAPA records related to QC investigations for completeness and adequacy.
Review and approval of qualification, analytical method transfer, validation protocol and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
Training of QC and QA teams.
Work in partnership with Quality Control and Quality Assurance
Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements
MINIMUM EDUCATION/EXPERIENCE REQUIREMENTS
Science or Pharmacy Graduate or Equivalent
8years
REQUIRED SUCCESS ATTRIBUTE
Knowledge of GxPs, cGMP and other regulatory requirements.
Planning and Prioritization
Collaboration
Accountability
Compliance
Customer Service orientation
Secondary Success Attributes
People Connect
Attention to detail
Emotional control
Effective Communication & Problem solving
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.