QC Manager | Cipla | Mechanical Engineer Job

Job Purpose

To ensure that Quality Control functions are performed in accordance to Regulatory guidelines
To effectively manage the Quality Control department to ensure that service level agreements with other departments are met
To effectively plan, organize, lead and control the activities of the Chemistry, Microbiological, Packaging and In-Process laboratories and to ensure that the financial, safety and health, environmental and quality standards are achieved
To provide technical service to problems arising in the plant
To continuously review business systems, methods, and procedures to ensure effective and cost efficient administration of the QC department
Keeps abreast of developments by research, literature and attending symposium
Key Accountabilities

Management of the QC Function

Tests incoming raw materials and packaging components to defined specifications
Tests intermediates and finished products to defined specifications
In both cases the job holder must balance the rapid throughput needs of the business with its requirement for ensuring quality and meeting obligations
Rapid decisions are constantly required, but with a high level of integrity and professionalism and to meet the legal requirements
Develops, Implements and maintains systems for calibration of equipment and control of reference standards
Release or rejects raw materials/packaging materials based on compliance to specifications
Sampling of raw materials/packmats/ intermediates/bulk/finished packed product
Approve specifications for above materials to ensure quality requirements are defined and meet current requirements
Assesses and documents quality of products to specifications and reports results to QA
Reports timely all non-conformances (Out of Specification/Out of Trends/Deviation) to QA and leads the investigations.
Efficiency

Allocates the QC resources to best effect and ensures tasks are completed within specified timescales
To prepare the laboratory budgets (capital and overheads) and to control expenditure within the approved budgets
Analytical Improvements

Ensures the development of improved analytical test methods which utilize new technology or methodology improvements to improve the throughput speed or reliability of the methods
Decides the suitability of the method, Tech Transfer responsibility
Sets up and implements a reduced testing programme once justified/approved as above.
Technical Support

Provides support to quality control and manufacturing for resolution of analytical and quality related problems
Reviews and approves all QC specification, investigations and reports
Implements activities to prevent recurring of OOS and OOT attributed to QC function.
Employee Management and Development

Sets work objective, reviews performance and ensure the training, development and motivation of his team in order that they are competent in the analytical procedures before testing of any materials so it functions effectively and that all are able to realize their potential
Training in basic laboratory techniques, complex analytical techniques and computer systems
Provide ongoing training for staff/subordinates
Validation

Ensures that all test methods are validated before use in the laboratory
Is a member of the validations team for all manufacturing processes and procedures
Manufacturing Development Measures

Provides quality performance statistics which form trigger for continuous improvement of the quality system
Active input and involvement in problem solving through participation in the CI programme
Technology Transfer

Provides input on all quality control aspects
Ensures that stability studies are carried out on the first 2 production batches of all new products so that product quality is assessed throughout its shelf life
Provides and interprets the stability reports and makes recommendations to shelf life
Stability ensures that rolling stability studies are carried out on existing product per current SOP
Audits

Assesses the quality control systems in place for compliance through self audits of the various laboratories
Evaluates and reports on audits, implements and follows up on corrective action taken
Is a member of the team for assessment of quality systems compliance
Assists in external audits for contract laboratories
Business Operating System (Syspro/SAP)

Updates relevant QC related data
Ensures release of raw materials, packaging components and WIP via the system
Master Documents

Generate and implements SOP’s for the Quality Control function
Develops and approves raw material, finished product, packing materials monographs for new or revised.
Skills & Knowledge

Educational qualifications:

Degree/Diploma with chemistry as a major subject

Relevant experience:

5-8 years Quality control laboratory experience in pharmaceutical, chemical or allied industries, especially analytical techniques (HPLC and GC)

3 years supervisory. Managerial experience

Other

General Business Practices, Customer Supplier Knowledge,
Knowledge of Manufacturing Systems, Recruitment & Selection, Systems Knowledge (SYSPRO or other ERP), Regulatory guidelines,
Career Pathing, Lean Manufacturing, Health and Safety Requirements,
Best Operating Practices, Manufacturing Accounting and Job Knowledge