Sr. Manager Batch Certification
Year Dadra, Dadra and Nagar Haveli, India
Job Description
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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\xe2\x80\x99 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 10 years
REQUIRED SUCCESS ATTRIBUTE
- Knowledge of GxP\xe2\x80\x99s, 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
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Job Detail
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Job IdJD3259098
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationDadra, Dadra and Nagar Haveli, India
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EducationNot mentioned
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ExperienceYear