Sr. Officer / Executive Quality Assurance ( Ipqa & Qms ) - Api Plant
- CES LTD
- 4 - 8 years
- 2 months ago
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Job Description
Roles and Responsibilities
For IPQA
- BMR review.
- To ensure the line clearance to the production unit.
- To ensure all QA activities are carried out as per the Standard operating procedure.
- Issuance, Retrieval, Approval & Controlling of all Quality related Documents (i.e. CSOP, SOP, STP, GTP, Protocol, etc.)
- Preparation, Review, and Retrieval of SOP.
- Candidate must have relevant experience in IPQA API Industries.
- Should have good communication and interpersonal skills.
For QMS
- Direct involvement in Deviation and Process Investigation.
- Handling of Change Control, Process Validation, Qualification, APQR, and Trend Report.
- Handling Market Complaints, Audit Compliance Reports & QMS-related activities.
- Fundamental knowledge about the investigation process.
- Review site compliance reports as applicable and follow-ups for adequate closure through appropriate supporting documents and addendum reports from the site.
- Trending & evaluation of observations for management notification
- Identify specific areas of improvement based on emerging trends and provide/organize training to the site as and when required.
- Data collection, trend QMS data, and establishing emerging trends.
- Preparation of department SOP & Corporate policies/SOPs, as and when required.
- Assist in regulatory or external inspections for site readiness.
- To discuss the gaps identified during the review with the site SME / QA Head / CQ Lead for resolution.
Desired Candidate Profile
- Candidate must have relevant experience in QMS or IPQA - API Industries
- Should have good communication and interpersonal skills.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: SCL Lifesciences LtdLocation(s): Dera Bassi+ View Contact
Keyskills: Change Control IPQA QMS Investigation API Compliance Audit Compliance
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₹ -7 Lacs P.A
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CES LTD
SCL Lifesciences Ltd (formerly known as Saurav Chemicals Limited) is a leading API manufacturing company with 30 years of experience in the pharmaceutical industry. We operate two state-of-the-art manufacturing units in Derabassi one dedicated to the domestic market and the other focused on export...
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