Executive I

3 days ago

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

KEY ACCOUNTABILITIES
- 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)
- 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
- 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 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
- Trouble shooting activities.
- Identifying and correcting unsafe conditions or behaviours 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.

Education / Experience- M.Sc. Organic Chemistry- Min. 1 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.-
- Team Building.

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