KEY ACCOUNTABILITIES

1.Analysis and approval

Sampling, analysis and ascertaining quality of raw materials, packaging material, intermediates, In-process samples and API for Chemistry Ankleshwar. Testing of the method validation samples and process validation samples and cleaning validation. Perform analysis and documentation of API finished product stability study as per stability study protocol. Coordinating with Production, Stores and QCAA for Approval / Rejection of raw materials/finished product. Validation and verification of analytical procedures as per requirement. Reporting OOS / OOT results and deviations. Maintaining retained samples as per standard procedure. Assisting in investigation of customer complaint. Testing of new samples (Vendor approval) Training of subordinates Give required suggestion for corrective actions and to plan effective preventive actions for the up gradation of the quality system. To ensure proper maintenance of the stability samples and their management. Disposal of waste according to the approved procedures. Continual reduction in the waste generation and effluent management. Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of products and utilities.

Documentation

Generation, managing and archiving Documents including raw data, reports, COA etc as per requirements.

Preparation and implementation of the SOPs in the laboratories system.

Specification preparation and implementing for API raw material and API finished product according to requirement.

Maintaining LIMS data entries

Providing technical support in compiling Annual Product Review.

Analytical method development when required.

Executing on line documentation

Statutory documentation and management

QMS activities

Laboratory Management

Qualification and Validation of instruments/equipment’s

Appropriate training and guidance to the subordinates.

Safety in the laboratory.

Regular housekeeping and upkeep of the work area.

Maintaining adequate inventory of chemicals and reference standards.

Adapting relevant technologies and systems in Quality control.

Laboratory equipment calibration and their maintenance.

Generate up gradation plans as need basis.

Any other activity assigned by the In charge, Quality control

Quality, HSE and Compliance

Adhere to current GMP guidelines

Following ALCOA+++ practices during documentation and related activities

Compliance to local and international HSE norms

Regulatory compliance

ISO 14000 related activities

Regular Pharmacopoeia and regulatory requirement review for compliance

To participate in any regulatory/Customer inspection takes place at the site

Training of self and subordinates on quality and HSE systems

Team member

Member of validation team.

Participating in discussions and giving feedback to Manager, Quality control regarding on-going activities.

Other projects

Supporting new projects (analytical method development (need base), validation, verification)

Laboratory compliance by reviewing documents for completeness

Preventive maintenance, Instrument calibration

New Instrument Qualification

Coordination with OEMs/Service providers for timely services