Executive - Qc

20 hours ago

Ankleshwar, India Zentiva Group, a.s. Full time

KEY ACCOUNTABILITIES

1.Analysis and approval

Supporting in-process control sample testing by online analysis to support production activities Sampling, analysis and ascertaining quality of 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, CWH and QA 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.

Providing technical support in compiling Annual Product Review.

Analytical method development when required.

Executing on line documentation

Laboratory Management

Qualification and Validation of instruments/equipment

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 Analytics.

Laboratory equipment calibration and their maintenance.

Generate up gradation plans as need basis.

Any other activity assigned by the In-charge, Analytics

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, Analytics regarding on-going activities.

Other projects

Trouble shooting activities.

Participation in Industrial Excellence projects.

Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

Plant round in absence of QA and during IInd and IIIrd shift.

Online checking of critical process parameters during round

REQUIREMENTS

Education / Experience

M.Sc. Organic Chemistry

Min. 2 years’ Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment

Technical skills &

Competencies / Language
- Technical competence
- Leadership skills
- Analytical ability
- Planning ability
- Communication skills
- Problem solving

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