Title:  Manager - 1

Position:

Manager - 1

Job Title:

QA Block Head

Job Grade:

G10(G10)

Function:

Quality

Sub-function:

Quality Assurance

Manager’s Job Title:

Senior Manager – 1

Skip Level Manager’s Title:

Quality Assurance Head

Function Head Title:

Quality Assurance Head

Location:

Dewas

No. of Direct Reports (if any)

07

Areas of Responsibility

Responsibilities :

• Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations.
• To release / reject the Batch after complete review of batch and related quality documentation.
• Conduct certification of BPR after completion of batch.
• Review and approve equipment qualification protocols and reports for accuracy, completeness, and traceability as well as adherence to protocol / procedures.
• Review and approve Annual Product review reports for the products as per the schedule.
• Track to completion all deviation and investigations related to product release.
• Conduct thorough investigations into and complaints for products manufactured at the site and ensure on-time closure of complaints.
• Run reports in electronic systems to ensure that all requirements related to batch release are met.
• Work directly with planning, QC, other QA functions, and Regulatory Affairs to ensure batches are released to meet supply chain requirements.
• Participate in self-audits of facility and equipment in partnership with Manufacturing and Engineering to ensure readiness for operations.

• Identify continuous improvement opportunities to increase compliance, process clarity, and operational efficiency.
• Review and approve Master Formula (Manufacturing / Packing Instruction) and SOPs.
• Review and approve process validation protocols and reports for accuracy, completeness, and traceability and well as adherence to protocol / procedures.
• Review and approve of records in Trackwise system and ensure timely closure.
• To monitor timely initiation and completion of individual steps as per the work flow for all tackwise records.
• Provides appropriate training and development to support staff to meet their respective job responsibilities.

Work in partnership with manufacturing, Engineering, and QC to increase knowledge and understanding of cGMP’s and improve practices and procedures.

Travel Estimate

Position is based out of Dewas SGO and has no travel requirements

Job Scope

Internal Interactions (within the organization)

All production block heads, supply chain team and other cross functional departments

External Interactions (outside the organization)

With Vendors

Geographical Scope

Position is based out of Dewas SGO and shall look after Block Quality Assurance for Dewas Site

Financial Accountability (cost/revenue with exclusive authority)

Finance Head

Job Requirements

Educational Qualification

B.Pharma /M.Pharma

Specific Certification

Skills

• Lead Block Quality Assurance Team.
• Ensure that batch production records are executed and reviewed in accordance with established SOPs and cGMP regulations
• To release / reject the Batch after complete review of batch and related quality documentation.

Experience

10-15 Years of experience

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).