Batch Certification Lead

3 weeks ago

Dadra amp Nagar Haveli, India SUN PHARMA Full time

Job Title
Sr. Manager – Batch Certification Lead

Business Unit
Global Quality & Compliance

Job Grade
G9B

Location :
Mumbai

At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."

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).
This role will be an individual contributor with expert in manufacturing investigations from FDA approved facilities that make sterile and OSD products.
The incumbent will assure individual compliance with 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.
  • QA SME for manufacturing & packaging Investigations (Sterile & OSD)
  • Batch Certification activities at Dadra and possibly other sites in India.
  • Experience in manufacturing contract manufacturing organizations, inculding Batch records, investigations and product quality compliants.
  • Experience in FDA and Health Canada inspections
  • 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.

Travel Estimate
Job Requirements
Educational Qualification
B.Pharm / M.Pharm

Experience
Tenure : 15 to 17 Yrs

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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