Symbiotec - Site Quality Head

Symbiotec Pharmalab Pvt. Ltd.

Date: 13 hours ago

City: Ujjain, Madhya Pradesh

Contract type: Full time

Job To ensure preparation, review and approval of all procedures, in line with the regulatory guidelines/ expectations, identify the gaps and update the procedure.

To handle the day today changes, deviations, incidents, market complaints, OOS, OOT are investigated in line with regulatory expectations in time bound fashion.
To develop second line personnel's by training the operating level and supervisors /reporting authorities to evaluate and implement the risk and science-based approach in decision making.
To coordinate with different functions like R&D, production, engineering, RA, purchase, compliance, marketing etc.
To bring about a robust system to ensure that it meets the regulatory.
Ensure that the analytical tech transfer is a well planned process and successful at the site.
To conduct training for all technical staff, inculcate the culture of quality and compliance, and have the schedules adhered to as per the training calendar.
To host the audits by customers and regulatory authorities.
To provide regulatory / customer audit response in conjunction with corporate quality and deep track on the CAPA's for time bound closures.
To be actively involved in all investigations related to the quality issues at the site, to help the marketing team and the customers get the required technical clarifications in a timely manner, etc.
To identify, understand and evaluate the need for infrastructural requirements and to organize for the timely procurement of such requirements to improve the efficiency and effectiveness of the quality functions.
To derive mechanism for measurement of productivity and achieve organizational goal of QA&QC.
To ensure all marketing requests are responded to in a timely manner.
To track and update closure of all quality notifications in a timely manner.
To ensure quality trends of products are prepared and reviewed in timely.
To ensure all regulatory queries related to analytical validation are responded to in a timely manner.
To ensure all qualification and Validations are successfully carried out as per schedule.
To ensure Annual Product Review is prepared and approved in a timely manner.
To steer and participate Quality Management review of Level-1 and level-2 at site.
To participate in Quality Management review level-3 and present it to the top Management.
Preferable candidate should be from Biotech/ Pharmaceutical API industry only.

(ref:iimjobs.com)

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

SC QC Supervisor

PepsiCo, Ujjain, Madhya Pradesh

2 weeks ago

OverviewJob Overview:This position is overall responsible for providing Quality Leadership at site. It is also responsible for driving Quality systems at site through proactive team participation and leading Food Safety Programs including AIB & FSSC.Responsible for maintaining the incoming Raw Material Quality, In Process quality compliance and ensuring FG quality through quality Assurance mindset.The position ensures compliance to Quality guidelines...

Associate Manager-Acquisition (Household)

IDFC FIRST Bank, Ujjain, Madhya Pradesh

2 weeks ago

Job RequirementsJob Requirements Role/ Job Title: Associate Manager-Acquisition (Household)Function/ Department: Branch BankingJob PurposeRole entails acquiring new customers for the bank's savings accounts. The role involves identifying potential customers, contacting them through various channels, explaining the benefits and features of the savings products, and closing the sales. Also to ensures that the customers are satisfied with the bank's services and maintains...

Lingerie Experts

IndisJob, Ujjain, Madhya Pradesh

4 weeks ago

Job Overview: Lingerie Experts role at Reliance Retail in Ujjain . Job Overview:Reliance Retail is seeking experienced Lingerie Experts to join our team. As a Lingerie Expert, you will be responsible for providing exceptional customer service and professional fitting services to our customers. You will play a key role in helping customers find the perfect lingerie pieces and ensuring they...