Skills:
Communication, Advertising, Public Relations, Research, Ad Serving, Key Performance Indicators, Multitasking, Strategy, Job Title: Department: Plant / Division / Sub-Department: Location: Responsibilities: Job Responsibility Head Quality Assurance (Formulation) Quality Assurance (Formulation) Formulation Plant All Formulation Plants
- Quality Management System: Ensure implementation of company quality policy.
Self Inspection System.
Responsible for Product Quality Review.
Responsible to coordinate management review meetings.
- Change control Proposals:
Approval / Rejection of changes recommended through Change Control Procedures. (CCP).
Ensure effective control over process and system through IPQC activity, Change control, and incidents, Deviations, OOS and CAPA.
- Planned / Unplanned Deviation Proposal:
- Handling Market Complaint:
To lead and guide the investigation to be carried out against Market Complaints, deviations, out of Specification incident management, OOS & CAPA etc. investigation, failure result,
- Product Recall Management:
To report Technical issues / progress, concerns to senior management with set periodicity. To support for FAR & Recall (If any) and to guide and CHRD:26//12/2023 Page 1 of 5 monitor corrective & preventive action.
- Preparation and Control of SOP's:
To approve Standard Operating Procedures pertaining to the plant.
- Documentation of IQ/OQ/PQ: Coordination with respected department
- Co-ordination with other departments:
To implement, suggest improvements in Corporate Quality guidelines.
Provide support to projects/Engineering department with respect to CFR part 11 and validation/qualification activities.
- Implementation of cGMP & USFDA systems:
- Document and data control:
Control key documents like site master file, master validation plan.
- Monitoring of stability studies:
To ensure correct stability monitoring as ICH guidelines / customer specific requirement and feedback to corporate.
- Annual product Review Management:
- Training of Quality Assurance SOP's:
To approve training Calender and conduct cGMP related training regular intervals as per the calendar.
Management and control of documents.
- Control of Non Conforming products:
- Participation in Technology Transfer:
Ensure effective technology transfer for Contract givers (CG) and other products. CHRD:26//12/2023 Page 2 of 5
Responsible to release / rejection of raw materials, packing materials intermediates and drug products as per the procedure.
- Regulatory Requirements: To lead the regulatory and international customers audits and to ensure compliance of the deficiencies within stipulated time.
- Qualification of equipments & instruments: To ensure Qualification and re-qualification od equipment and instruments, ensure correctness of the report and approve the qualification reports. To ensure CFR part 11 compliance to all instruments, PLC's and computerized system.
- Manpower: Ensure process validation, Analytical validation and documentation for the same. To evaluate performance of subordinates and organizing training & change in job responsibilities, etc.
- Safety:
To confirm requirement of the plant for E.H.S Compliance. the effective management of safety
CHRD:26//12/2023 Page 3 of 5 Key Competencies:
Qualification
Experience
- Essential
- Desirabl Functionally reporting to: (Designation) Administratively reporting to: (Designation) CHRD:26//12/2023 Page 4 of 5 Current holder of the position: (Name & Designation) Responsible person in case of absence: (Name & Designation) Signature: Name: Designation & Grade: Date: Head of Department: Current Job Holder: Signature: Name: Designation & Grade: Date: CHRD:26//12/2023 Page 5 of 5
