Sr. Manager Batch Certification

1 week ago

Dadra and Nagar Haveli, India SUN PHARMA Full time

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

Graduate in Pharmacy or equivalent field. Masters preferred.

10 years of experience in Pharma Industry

REQUIRED SUCCESS ATTRIBUTE

Knowledge of GxP's, 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

Roles

Additional responsibilities can be assigned as required.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.

DELEGATION OF RESPONSIBILITY

In the absence of job holder, delegation of responsibility will be as follows:

Upward Delegation – Strategic site responsibilities to higher level

Downward Delegation – Operational responsibilities to direct reports or similar job role

___________________ __________

Department Head Date

____________________ __________

Human Resources Date

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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