Quality Control Assistant Manager

Job description:

Position: Assistant Manager

Department: Quality Control

JOB RESPONSIBILITIES:

Ø Ensuring that the QC chemical department is maintained properly in compliance with good laboratory practices and all relevant regulatory guidelines.

Ø Implementing Quality Management Systems in the laboratory.

Ø Initiating, checking, reviewing and approving (as applicable) the QMS documents such as change control, deviation, CAPA, OOS/OOT, Lab event, etc.

Ø Reviewing and investigating out of specifications results, atypical results and laboratory deviations, laboratory event investigation as per laid down SOP.

Ø Ensuring that each employee is trained in the respective job areas related to SOPs, Procedure/Job specific training, analyst qualification, before they perform any activity / analysis in the laboratory.

Ø Ensuring that specifications and method of analysis, adequate facility and other applicable resources required for testing, release, rejection of all raw materials, packing materials, in process, intermediates, container & closures and finished products are made available.

Ø Ensuring that all equipment used in the laboratory is qualified and regularly calibrated in accordance with respective SOPs.

Ø Managing annual maintenance contracts for instruments, calibration, preventive maintenance, and CSV of all the lab instruments/equipment.

Ø Ensuring proper sampling of all incoming raw and packing materials in accordance with respective SOPs.

Ø Monitoring and ensuring adequate testing of raw materials, packaging materials, in-process, and finished products as per specifications and method of analysis.

Ø Monitoring product and cleaning method development along with validation.

Ø Ensuring smooth transfers of analytical methods of technology from R&D to Manufacturing Facility.

Ø Ensuring that a stability-testing program is in place to monitor the stability characteristics of new and regular products.

Ø Ensuring all the analysis of samples is being done within the permitted time period as per SOP.

Ø Ensuring stability reports are timely prepared, signed off on, and made available.

Ø Auditing the external testing laboratory, raw material, and packaging material vendors as and when required.

Ø Participating in root cause analysis (RCA), risk assessment, all relevant investigations and ensure that they are carried out as per applicable SOPs.

Ø Ensuring compliance with Dynamic’s ethical committee’s policies and reporting to committee concerning issues that raise ethics concerns.

Ø Responding to audits mandated by regulatory authorities; conducting internal audits as may be required by applicable SOPs.

Ø Ensuring the overall development of the quality control department and helping to achieve the highest levels of quality, integrity, and reliability of results.

Ø Identifying resource requirements, including availability of adequate human resources, capital items and consumables in the department.

Ø Providing support to cross-functional departments for the development and implementation of quality systems.

Ø Ensuring the adequate laboratory resources are available.

Ø Reviewing and approving the purchase requisition for laboratory consumables and CAPEX for laboratory instruments/equipment.

Ø Works as a member of a team to achieve all outcomes.

Ø Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.

Ø Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.

Ø All other relevant duties assigned.

Benefits

Ø Competitive Salary/Hourly Rate

Ø Medical, Dental, Vision Insurance

Ø Paid Time Off & Holidays

Physical Demands:

· Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care.   

· KriGen Pharmaceuticals is an equal opportunity employer.  All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law.  Background checks and drug screens are part of our hiring process.  Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person