Executive​/Sr. Officer-MSTG

Executive/Sr. Officer-MSTG

Business Unit: MSTG

Job Grade: G12A/12B

Location:

Jammu

• To provide support for execution and monitoring of trial, scale up and exhibit batches.
• To prepare new product documents like material requirement sheet, batch manufacturing record, bill of material, risk assessment reports, contamination reports, sampling protocol, reports, exhibit batch manufacturing record and exhibit protocols and reports etc.
• To prepare new product documents like sampling protocol and trial batchreportsinvestigation report/Justification report,additional activity protocol, regulatory evaluation etc.
• To provide the regulatory response.
• To send samples of trial / exhibit batches to formulation and development department.
• To conduct training of protocols for batch execution.
• To prepare site transfer documents and provide support during site transfer activities of the products.
• Tomonitorthe scale up batch/characterization batch and process qualification batches if required.
• To share process knowledgetocross functional departments through presentation for smooth technology transfer whenever required.
• To prepare investigation report/Justification report,additional activity protocol, regulatory evaluation etc.
• To prepare and evaluate product history and process parameters for technical remediation and improvement of product robustness.
• To prepare andsubmitthe investigation reports for OOS, OOT and any failure for exhibit/validation/commercial batch manufacturing and during stability testing.
• To prepare product containment approach and risk assessment for new product.
• To prepare and arrange placebo for quality control testing if required.
• Toparticipatein various regulatory audits to support the plant.

M.Pharma

Tenure: 2-5 Years

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth.

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).

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.