ROLES AND REPONSIBILITIES OF DGM QA

Role of DGM QA is to lead the Quality assurance team to implement QMS in the
operations of development, purchase, Quality control, production, distribution, and Storage.
Assuring the products quality to meet customer expectation by covering all matters that
individually or collectively influence the quality of a product,
The broad responsibilities are

1.0 Accomplishes quality assurance human resource objectives by

Recruiting, selecting, training, employees; communicating job
Expectations; planning, monitoring, appraising, and reviewing job Contributions.

2.0 Approval, control and distribution of quality documents like SMF, Quality Manual,
SOPs, Validation protocols, reports, and Specifications.

3.0 Review of SOPs, Non-conformances, Process deviations, Change controls, Market

complaints and Product quality review data on regular basis.

4.0 Preparation of Validation Master Plan/ Calibration plan and implementation of the
validation/ calibration schedules.

5.0 To plan, organize and conduct Self-inspections and arrange review meeting to
ensure the implementation of proposed corrective and preventive actions.

6.0 Qualification and Validations of equipment and processes.

7.0 Batch failure and OOS Investigations ensuring appropriate Corrective and Preventive
actions ( CAPA )

8.0 Management of External Inspections and to ensure the deficiency corrections well
within the stated time frame.

9.0 Preparation and organising of Technical Training Program.

10.0 Vendor development and vendor audits.

11.0 Document retention and maintenance

12.0 Handling of all regulatory audits with appropriate CAPA for the deficiencies agreed
upon.

13.0 Art Work and Packing materials Control.

14.0 Stability study Planning and data monitoring.

15.0 Annual Product Review

16.0 Training on Technical aspects.

ROLES AND REPONSIBILITIES OF DGM QC
Role of DGM QC is to lead the Quality control team to inspect, test and certify all the
incoming, semi processed and finished products.
The broad responsibilities are
To Monitor the quality of all incoming Raw Materials , Packing Materials and finished products
being manufactured at TTK Pallavaram facility.

To conduct stability studies of existing and new products

To develop new analytical procedures.

Validation of analytical methods.

To attend market complaints.

To co-ordinate with marketing dept for their new product.

To approve artworks.

To comply with government regulation from time to time implement in laboratory.

To monitor calibration and maintenance of all instruments

To monitor microbiological quality of all products, water, environment.

To train the chemists in their job.

To teach the chemist about new procedures & make them understand new developments in the
industry.

To co-ordinate with suppliers for AMC .

ROLES AND REPONSIBILITIES OF DGM R & D
Role of DGM R & D is to lead the Formulation development team to develop new product ,
improve process and provide technical information to concern departments.
The broad responsibilities are

 Development of various Pharmaceutical Dosage forms.

 Technology Transfer and scale up activities.
 Process validation & stability studies.
 Preparation of Master Formula Records (MFRs), Standard Operating Procedures
(SOPs) etc.
 Trouble shooting at shop floor.
 Coordination with Contract Research Organizations for performing Pre-clinical /
Clinical studies.
 Artwork and Packaging Development.
 Providing awareness and training at suitable intervals for Technical and Non-
Technical personal.
 Coordination with Marketing Dept (Domestic & International Business).
 Dossier preparation and review for various International Markets according to
guidelines.
 Manufacturing operations support.
 Ensuring GMP compliance with systems for quality operations.
 Equipment qualification activities.
 Ensuring Systems for Materials Dispensing.
 Managing procurement of materials.
ROLES AND REPONSIBILITIES OF Sr.MANAGER PRODUCTION
Role of Production manager is heading manufacturing planning and its related activities
The broad responsibilities are

 Prepare production plan for the month,

 Co ordinating with Purchase and Stores regarding the availability of Raw and Packing
material.
 Responsible for production activities and organizing manpower.
 Coordination with Stores and Quality Control department for dispensing RM & PM.
 Ensuring GMP and safety measures.
 Complete Batch Manufacturing Records
 Preparing and updating documents required for production.
 Identify and take necessary corrective action in production related issues.
 After packing is completed, subject to approval, send daily packing details to Supply
Chain.
ROLES AND REPONSIBILITIES OF EXECITIVE MAINTENANCE
Role of Maintenance executive is heading plant and equipment maintenance
The broad responsibilities are

 Executing and monitoring preventive maintenance work pertaining to Production

Machineries, Utility and ETP as per standards.

 Preparing and maintaining of ISO and GMP documents.

 Planning and performing repair and maintenance works at plant.

 Maintaining Annual Maintenance Contract for Lift, Generator, Fire Extinguishers, etc.

 Maintaining all Material Purchase Requisition and Indent log book.

 Coordinating License Renewal for Boiler, Explosives storage, TNEB, Lift, etc.,

 Co-ordination with various vendors for service related issues.

 Co-ordination with TNEB persons for certain day to day issues in the plant.

 Co-ordination with Accounts dept for HT and LT monthly bills, monthly consumption
statement (oil and energy).

 Maintaining and monitoring the Diesel, Furnace oil, Caustic soda, Hydrochloric acid usage
along with stock details.

 Coordinating with purchase department for service bills and payment.

 Co-ordination in preparing engineering drawings.

ROLES AND REPONSIBILITIES OF MANAGER PURCHASE
Role of Manager Purchase is heading purchase operation of all input materials required for
plant operation
The broad responsibilities are

 Planning for material requirement after receiving production plan.

Raising PO as per the requirement and Follow-up with supplier’s for delivery of materials
on time.

 Ordering Sundry items.

 Preparing MIS invoice

 Preparing service order

 Preparing purchase order for asset/ heart valve and follow up for payments.

 Bill passing for sundries/ stationery/ MIS items.

 Bill passing and organizing materials for Third party manufacturers.

 Follow up with Accounts dept for suppliers payment.

 Liasoning with stores and production

 Daily update for ISO documentation.

 Furnace oil & diesel oil procurement.

 Continuous monitoring and updating of rates

 Maintaining lower inventory

Updating vendor rating